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UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. LEGAL AND PRACTICAL ISSUES IN THE EVOLVING WORLD OF What’s the Buzz? Cannabis-derived products are at a dynamic legal and regulatory crossroads at both the state and federal level. While cannabis-derived substances above 0.3% THC are still illegal at the federal level, states are continuing to legalize cannabis for medical and/or recreational use; many states even designated cannabis businesses as “essential” during the initial phases of REGENERATIVE MEDICINE CONFERENCE AGENDA During this session, speakers will first examine FDA’s Framework for supporting and expediting regenerative medicine product development, including the status of new and upcoming guidances. The panel will also discuss FDA’s inter-Center coordination to FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE Food Advertising, Labeling, and Litigation Conference - Food and Drug Law Institute (FDLI) Email Updates. Become a Member. 800-956-6293. in fo@fdli.org. Log In. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE With this in mind, we are excited to announce that the 2021 Advertising and Promotion for Medical Products Conference will be a virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers. Be sure to check the course website regularlyfor
ORPHAN DRUGS IN CANADA: A “ONE SIZE FITS ALL” REGULATORY Orphan Drugs in Canada: A “One Size Fits All” Regulatory Regime. By Eileen McMahon and Denise Ramsden . Introduction. Medicines targeting rare diseases, also known as orphan drugs, once faced an uphill battle for research funding and market approval. The need for robust commercial incentives to create rare disease treatments spurred the establishment of international orphan drug TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Join a diverse group of stakeholders – public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others – for this three-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the US.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. LEGAL AND PRACTICAL ISSUES IN THE EVOLVING WORLD OF What’s the Buzz? Cannabis-derived products are at a dynamic legal and regulatory crossroads at both the state and federal level. While cannabis-derived substances above 0.3% THC are still illegal at the federal level, states are continuing to legalize cannabis for medical and/or recreational use; many states even designated cannabis businesses as “essential” during the initial phases of REGENERATIVE MEDICINE CONFERENCE AGENDA During this session, speakers will first examine FDA’s Framework for supporting and expediting regenerative medicine product development, including the status of new and upcoming guidances. The panel will also discuss FDA’s inter-Center coordination to FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE Food Advertising, Labeling, and Litigation Conference - Food and Drug Law Institute (FDLI) Email Updates. Become a Member. 800-956-6293. in fo@fdli.org. Log In. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE With this in mind, we are excited to announce that the 2021 Advertising and Promotion for Medical Products Conference will be a virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers. Be sure to check the course website regularlyfor
ORPHAN DRUGS IN CANADA: A “ONE SIZE FITS ALL” REGULATORY Orphan Drugs in Canada: A “One Size Fits All” Regulatory Regime. By Eileen McMahon and Denise Ramsden . Introduction. Medicines targeting rare diseases, also known as orphan drugs, once faced an uphill battle for research funding and market approval. The need for robust commercial incentives to create rare disease treatments spurred the establishment of international orphan drug TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
LEGAL AND PRACTICAL ISSUES IN THE EVOLVING WORLD OF What’s the Buzz? Cannabis-derived products are at a dynamic legal and regulatory crossroads at both the state and federal level. While cannabis-derived substances above 0.3% THC are still illegal at the federal level, states are continuing to legalize cannabis for medical and/or recreational use; many states even designated cannabis businesses as “essential” during the initial phases of AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT Join FDLI at the first “Author Happy Hour” for the Summer 2021 issue of Update magazine to discuss the article, “Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations.”Theodora McCormick of Epstein Becker Green will lead a discussion on the evolution of food and dietary supplement class action suits from those historically based on allegations of deceptive REGENERATIVE MEDICINE: REGULATORY, LEGAL, AND COMPLIANCE Julie Allickson, Wake Forest University Mantej Nimi Chhina, BioMarin Pharmaceutical Inc. Jennifer Devine, U.S. Pharmacopeia Lynn Ensor, Parexel International Corporation Allison Fulton, Sheppard Mullin Richter & Hampton LLP Colleen M. Heisey, Jones Day Chin C. Koerner, Novartis Pharmaceuticals Corporation Diane M. Maloney, FDA – CBER Sung Park, Reed Smith LLP PHARMACEUTICAL GMPS, QUALITY CONTROL, AND DATA: A DEEPER Pharmaceutical GMPs, Quality Control, and Data: A Deeper Look at FDA’s FY 2020 FDA Observations. By Amy Scanlin. Good Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products. Though clearly articulated by FDA, a review of FY 2020 pharmaceutical inspection observational UNDERSTANDING NICOTINE: HEALTH IMPACTS, PUBLIC CLIFFORD E. DOUGLAS is Director at the University of Michigan Tobacco Research Network and an Adjunct Professor at the University of Michigan School of Public Health.He is a long-time expert on a wide range of tobacco-related policy, regulatory and legal issues, ranging from federal regulation of tobacco products and the challenges and potential benefits of e-cigarettes to the widening 2021 TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Why Attend Last Year's Agenda CLE A preliminary agenda is to be announced 2021. If you would like to be notified, please let us know . Wednesday, October 21 10:30 – 10:55 AM Technology and Connection Support Session First virtual conference? Unsure REGULATIONS OF CAR T-CELL THERAPIES—THE PAST, PRESENT, AND Regulations of CAR T-Cell Therapies—The Past, Present, and Future . By Shraddha Komanduri . Introduction. The field of oncology has always spurred interest and motivated researchers to develop drugs to address the mortality and quality of life associated with cancers. THE LEGALIZATION OF HEMP The 2018 Farm Bill defines hemp as Cannabis sativa L. and “any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers,” with no more than a 0.3 percent concentration of THC. Any cannabis plant that contains more than 0.3 percent THC falls outsidethe scope of
ORIGINS AND ORGANIZATIONAL STRUCTURE OF FDA OVERVIEW OF Biologics Regulation— Where we start It started with a horse 1902 Biologics ControlAct: In 1901, a 5-year-old girl died of tetanus in St. Louis, Missouri after being given a diphtheria anti- COMMUNICATING EMERGING DRUG THERAPIES PRIOR TO FDA 6 Rise of commercial speech doctrine Valentine v. Chrestensen Virginia State Board of Pharmacy Central Hudson Emerging shifts in case law Washington Legal Found. (D.DC 1999) Western States (US 2002) IMS v. Sorrell (US 2011) New cases United States v. Caronia (2d Cir. 2012) Amarin v. FDA (SDNY 2015) Town of Gilbert (US 2015) Pacira v. HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI) For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI) FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Join a diverse group of stakeholders – public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others – for this three-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the US. AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT Join FDLI at the first “Author Happy Hour” for the Summer 2021 issue of Update magazine to discuss the article, “Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations.”Theodora McCormick of Epstein Becker Green will lead a discussion on the evolution of food and dietary supplement class action suits from those historically based on allegations of deceptive FOOD AND DRUG LAW JOURNAL The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE With this in mind, we are excited to announce that the 2021 Advertising and Promotion for Medical Products Conference will be a virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers. Be sure to check the course website regularlyfor
FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE Food Advertising, Labeling, and Litigation Conference - Food and Drug Law Institute (FDLI) Email Updates. Become a Member. 800-956-6293. in fo@fdli.org. Log In. HIGHLIGHTS AND INSIGHTS FROM THE GENERAL SNUS MODIFIED Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents . By James M. Solyst. INTRODUCTION. The October 22, 2019 Food and Drug Administration (FDA) decision to authorize the marketing of the Swedish Match USA line of General snus products as Modified Risk Tobacco Products (MRTPs) was a much-needed statement of support for tobacco harm reduction COMPLIANCE CENTRAL WITH FDA CDER COMPLIANCE DIRECTOR Compliance Central with FDA Center Compliance Directors: Part I Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA Erin Keith, Associate Director for Compliance and Quality, Center for Devices and Radiological Health, FDA Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality,Center for
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI) For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI) FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Join a diverse group of stakeholders – public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others – for this three-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the US. AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT Join FDLI at the first “Author Happy Hour” for the Summer 2021 issue of Update magazine to discuss the article, “Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations.”Theodora McCormick of Epstein Becker Green will lead a discussion on the evolution of food and dietary supplement class action suits from those historically based on allegations of deceptive FOOD AND DRUG LAW JOURNAL The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE With this in mind, we are excited to announce that the 2021 Advertising and Promotion for Medical Products Conference will be a virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers. Be sure to check the course website regularlyfor
FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE Food Advertising, Labeling, and Litigation Conference - Food and Drug Law Institute (FDLI) Email Updates. Become a Member. 800-956-6293. in fo@fdli.org. Log In. HIGHLIGHTS AND INSIGHTS FROM THE GENERAL SNUS MODIFIED Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents . By James M. Solyst. INTRODUCTION. The October 22, 2019 Food and Drug Administration (FDA) decision to authorize the marketing of the Swedish Match USA line of General snus products as Modified Risk Tobacco Products (MRTPs) was a much-needed statement of support for tobacco harm reduction COMPLIANCE CENTRAL WITH FDA CDER COMPLIANCE DIRECTOR Compliance Central with FDA Center Compliance Directors: Part I Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA Erin Keith, Associate Director for Compliance and Quality, Center for Devices and Radiological Health, FDA Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality,Center for
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Always informative and entertaining, this perennially popular session promises insight into the most significant current litigation and a look at cases to keep an eye on in the coming year. Annual Conference attendees receive the companion e-publication, Top Food and Drug Law Cases 2020, and Cases to Watch, 2021. CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI) For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI) FDLI invites you to submit a proposal recommending a topic for an upcoming webinar. Ideas related to all FDA-regulated industries are welcome! Webinar Topics Can Address: Ideas, Trends, and Current Hot Topics in Food and Drug Law. Ideas for Professional Development. Topics for Beginner/Intermediate/Advanced Level Regulatory or LegalPractitioners.
TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Join a diverse group of stakeholders – public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others – for this three-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the US. FOOD AND DRUG LAW JOURNAL The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT Join FDLI at the first “Author Happy Hour” for the Summer 2021 issue of Update magazine to discuss the article, “Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations.”Theodora McCormick of Epstein Becker Green will lead a discussion on the evolution of food and dietary supplement class action suits from those historically based on allegations of deceptive FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE Food Advertising, Labeling, and Litigation Conference - Food and Drug Law Institute (FDLI) Email Updates. Become a Member. 800-956-6293. in fo@fdli.org. Log In. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE With this in mind, we are excited to announce that the 2021 Advertising and Promotion for Medical Products Conference will be a virtual event. Please know we are actively exploring options to ensure an engaging and enjoyable experience with ample opportunities to connect with your peers. Be sure to check the course website regularlyfor
HIGHLIGHTS AND INSIGHTS FROM THE GENERAL SNUS MODIFIED Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents . By James M. Solyst. INTRODUCTION. The October 22, 2019 Food and Drug Administration (FDA) decision to authorize the marketing of the Swedish Match USA line of General snus products as Modified Risk Tobacco Products (MRTPs) was a much-needed statement of support for tobacco harm reduction COMPLIANCE CENTRAL WITH FDA CDER COMPLIANCE DIRECTOR Compliance Central with FDA Center Compliance Directors: Part I Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA Erin Keith, Associate Director for Compliance and Quality, Center for Devices and Radiological Health, FDA Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality,Center for
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Why Attend Agenda Agenda Subject to Change. All Times are Eastern Time. CLE Tuesday, May 18 Amy Comstock Rick, President & CEO, FDLI Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference Janet CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE Webinars. FDLI webinars provide timely education in a convenient format. Webinars are typically 90 minutes, and offer downloadable slides and interactive features such as READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Why Attend Agenda Agenda Subject to Change. All Times are Eastern Time. CLE Tuesday, May 18 Amy Comstock Rick, President & CEO, FDLI Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference Janet CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE Webinars. FDLI webinars provide timely education in a convenient format. Webinars are typically 90 minutes, and offer downloadable slides and interactive features such as READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI) For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels. TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Join a diverse group of stakeholders – public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others – for this three-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the US. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI) Webinars. FDLI webinars provide timely education in a convenient format. Webinars are typically 90 minutes, and offer downloadable slides and interactive features such as AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT Join FDLI at the first “Author Happy Hour” for the Summer 2021 issue of Update magazine to discuss the article, “Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations.”Theodora McCormick of Epstein Becker Green will lead a discussion on the evolution of food and dietary supplement class action suits from those historically based on allegations of deceptive FOOD AND DRUG LAW JOURNAL The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE October 13–15, 2021 | Virtual Event Register by 10/1/21 and SAVE FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE September 28–30, 2021 | Virtual Event Register by 9/17/21 and SAVE HIGHLIGHTS AND INSIGHTS FROM THE GENERAL SNUS MODIFIED Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents . By James M. Solyst. INTRODUCTION. The October 22, 2019 Food and Drug Administration (FDA) decision to authorize the marketing of the Swedish Match USA line of General snus products as Modified Risk Tobacco Products (MRTPs) was a much-needed statement of support for tobacco harm reduction COMPLIANCE CENTRAL WITH FDA CDER COMPLIANCE DIRECTOR Compliance Central with FDA Center Compliance Directors: Part I Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA Erin Keith, Associate Director for Compliance and Quality, Center for Devices and Radiological Health, FDA Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality,Center for
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Why Attend Agenda Agenda Subject to Change. All Times are Eastern Time. CLE Tuesday, May 18 Amy Comstock Rick, President & CEO, FDLI Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference Janet CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE Webinars. FDLI webinars provide timely education in a convenient format. Webinars are typically 90 minutes, and offer downloadable slides and interactive features such as READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
HOME - FOOD AND DRUG LAW INSTITUTE (FDLI)VIRTUAL LEARNINGPROGRAMSRESOURCESGET INVOLVEDCAREERABOUT The Food and Drug Law Institute (FDLI), founded in 1949, is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the 2021 FDLI ANNUAL CONFERENCE AGENDA Why Attend Agenda Agenda Subject to Change. All Times are Eastern Time. CLE Tuesday, May 18 Amy Comstock Rick, President & CEO, FDLI Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference Janet CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTENATIONAL DRUG COURT INSTITUTETN LAW INSTITUTELAW ENFORCEMENT INSTITUTE For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels.UPDATE MAGAZINE
Update EXTRA. Update EXTRA is an occasional electronic-only feature of Update magazine designed to provide interviews, reporting, and analysis on emerging issues of broad interest to our community. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI)IL LAW INSTITUTEINTERNATIONAL LAW INSTITUTE Webinars. FDLI webinars provide timely education in a convenient format. Webinars are typically 90 minutes, and offer downloadable slides and interactive features such as READY OR NOT, HERE IT COMES! THE DRUG SUPPLY CHAIN Part II: DSCSA Enforcement On February 7, 2019, FDA issued a Warning Letter to McKesson Corporation, a wholesale drug distributor, following a Form FDA 483 issued in connection with a 2018 inspection of the firm’s corporate headquarters and a distribution facility.This marks the first Warning Letter issued by the Agency citing violations of DSCSA provisions currently in effect. THE LEGALIZATION OF HEMP SCIENTIFIC EXCHANGE: GREY AREAS AND BEST PRACTICESSCIENTIFIC EXCHANGE DEFINITIONSCIENTIFIC EXCHANGE VERSUS PROMOTIONSCIENCE EXCHANGE COMPANYSCIENCE EXCHANGE INCSCIENTIFIC MINDS Scientific Exchange: Grey Areas and Best Practices Susan Cantrell, Chief Executive Officer, Academy of Managed Care Pharmacy Kellie Combs, Partner, Ropes & Gray LLP Mark Gaydos, VP, NA General Medicines & Established Products/US Advertising & Promotion, Global Regulatory Affairs, Sanofi Moderated by Ellen Schumacher, Executive Director, Commercial Regulatory Affairs, Bristol- INTRODUCTION TO FDA REVIEW AND APPROVAL OF BIOLOGICAL PRODUCTS 3 Background on Biologics What is a biologic? –Simple definition: A medicine derived from living organisms –The FDA definition: A virus, therapeutic serum, toxin, antitoxin, vaccine, TOWARD A GLOBAL SOLUTION ON VACCINE LIABILITY AND 1 Toward a Global Solution on Vaccine Liability and Compensation JOHN D. WINTER, CASSYE COLE, AND JONAH WACHOLDER* ABSTRACT In the past fiveyears,
CAREER - FOOD AND DRUG LAW INSTITUTE (FDLI) For young professionals, the New to Food and Drug Law Group provides an additional avenue for learning and connecting. Our Introductory Courses offer a foundation for success as well as a valuable review for those with more experience. Students will benefit from these programs, too. The Career Center offers a chance to explore new opportunities at all levels. TOBACCO AND NICOTINE PRODUCTS REGULATION AND POLICY Join a diverse group of stakeholders – public health advocates, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs, governmental agencies, and others – for this three-day conference on effectively regulating the broad spectrum of tobacco and nicotine products in the US. WEBINARS - FOOD AND DRUG LAW INSTITUTE (FDLI) Webinars. FDLI webinars provide timely education in a convenient format. Webinars are typically 90 minutes, and offer downloadable slides and interactive features such as AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT Join FDLI at the first “Author Happy Hour” for the Summer 2021 issue of Update magazine to discuss the article, “Food and Supplement Class Action Suits That Rely on Alleged Regulatory Violations.”Theodora McCormick of Epstein Becker Green will lead a discussion on the evolution of food and dietary supplement class action suits from those historically based on allegations of deceptive FOOD AND DRUG LAW JOURNAL The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements FDLI ANNUAL CONFERENCE: EXPLORING ADVANCED TOPICS IN FOOD ERIKA F. LIETZAN is the William H. Pittman Professor of Law & Timothy J. Heinsz Professor of Law at the University of Missouri School of Law, where she focuses her teaching and scholarship on food and drug law, intellectual property, and administrative law.She’s currently working on an article relating to pharmaceutical trademarks and an article on medical device patents. ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE October 13–15, 2021 | Virtual Event Register by 10/1/21 and SAVE FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE September 28–30, 2021 | Virtual Event Register by 9/17/21 and SAVE HIGHLIGHTS AND INSIGHTS FROM THE GENERAL SNUS MODIFIED Highlights and Insights from the General Snus Modified Risk Tobacco Product Decision Documents . By James M. Solyst. INTRODUCTION. The October 22, 2019 Food and Drug Administration (FDA) decision to authorize the marketing of the Swedish Match USA line of General snus products as Modified Risk Tobacco Products (MRTPs) was a much-needed statement of support for tobacco harm reduction COMPLIANCE CENTRAL WITH FDA CDER COMPLIANCE DIRECTOR Compliance Central with FDA Center Compliance Directors: Part I Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, FDA Erin Keith, Associate Director for Compliance and Quality, Center for Devices and Radiological Health, FDA Melissa Mendoza, Deputy Director, Office of Compliance and Biologics Quality,Center for
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AUSTERN WRITING COMPETITION OPEN TO LAW STUDENTS INTERESTED IN THE AREAS OF LAW AFFECTING FDA-REGULATED INDUSTRIESPapers Due June 11
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THE ESSENTIALS OF CLINICAL TRIAL SCIENCE JUNE 16, 2021 | 2:00 – 3:30 PM EDT | LIVE WEBINAR _PART OF THE SUMMER LEARNING SERIES_Register Now
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CALL FOR SUBMISSIONS: FOOD AND DRUG LAW JOURNAL 2021 SYMPOSIUM ACCEPTING PAPER AND COMMENTARY ABSTRACTS THROUGH JUNE 28Submit Now
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FOOD AND DIETARY SUPPLEMENT CLASS ACTION LITIGATION: ROUNDTABLE DISCUSSION ON RECENT FILINGS AND CURRENT TRENDS JUNE 17, 2021 | 2:00 – 3:30 PM EDT | LIVE WEBINARRegister Now
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2021-06-03T09:55:09-04:00 _A MEMBERSHIP ORGANIZATION ENGAGING THE FOOD AND DRUG LAW COMMUNITY_FDLI NEWS
* Register Now: REGENERATIVE MEDICINE CONFERENCE * SUMMER LEARNING WEBINAR SERIES: June-July 2021
* Live Webinar: FOOD AND DIETARY SUPPLEMENT CLASS ACTION LITIGATION: ROUNDTABLE DISCUSSION ON RECENT FILINGS AND CURRENT TRENDSMEMBERS
* June’s Complimentary AUTHOR HAPPY HOUR: EVOLVING FOOD AND DIETARY SUPPLEMENT CLASS ACTION SUITS * Submit Your Ideas to Facilitate a LAW OVER LUNCHDiscussion
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* Due June 11: Law Students, Submit Papers for AUSTERN WRITINGCOMPETITION
* Call for Submissions Open Through June 28: _FOOD AND DRUG LAWJOURNAL_
2021 SYMPOSIUM
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2021-05-26T15:24:02-04:00 ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS CONFERENCE October 13–15, 2021 | Virtual Event REGISTER BY 10/1/21 AND SAVE*
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2021-05-24T10:03:39-04:00 FOOD ADVERTISING, LABELING, AND LITIGATION CONFERENCE September 28–30, 2021 | Virtual Event REGISTER BY 9/17/21 AND SAVE*
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2021-05-28T17:09:10-04:00 REGENERATIVE MEDICINE: REGULATORY, LEGAL, AND COMPLIANCE CHALLENGES FOR CELL AND GENE THERAPIES June 8–9, 2021 | Virtual EventMore Events
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INTRODUCTORY COURSES FDLI offers intensive training courses covering the basics of FDA lawand regulation.
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2021-04-22T15:52:53-04:00 INTRODUCTION TO ADVERTISING AND PROMOTION FOR MEDICAL PRODUCTS October 12, 2021 | Virtual Course REGISTER BY 10/1/21 AND SAVE*
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2021-03-15T09:01:18-04:00 INTRODUCTION TO BIOLOGICS AND BIOSIMILARS LAW AND REGULATION October 5–7, 2021 | Virtual Course REGISTER BY 9/24/21 AND SAVE*
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2021-03-19T08:51:04-04:00 INTRODUCTION TO FOOD LAW AND REGULATION September 21–23, 2021 | Virtual Course REGISTER BY 9/10/21 AND SAVE_UPDATE_ MAGAZINE
This publication provides concise articles on cutting-edge food anddrug law issues.
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2021-05-20T16:55:59-04:00 PHARMACEUTICAL GMPS, QUALITY CONTROL, AND DATA: A DEEPER LOOK AT FDA’S FY 2020 FDA OBSERVATIONSWEBINARS
FDLI webinars provide timely education in a convenient format and offer interactive features.More Webinars
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2021-05-27T15:23:20-04:00 FOOD AND DIETARY SUPPLEMENT CLASS ACTION LITIGATION: ROUNDTABLE DISCUSSION ON RECENT FILINGS AND CURRENT TRENDS LATEST TWEETS FROM @FOODANDDRUGLAW (SEE ALL)
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