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practice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyGAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.KARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDA DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.JAMES E. VALENTINE
James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyGAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.KARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDA DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.JAMES E. VALENTINE
James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues.ABOUT US - HPM
Why you’ll like working with us. Smart and committed: We care about the issues you care about, and we devote our resources to finding answers to the questions that keep you up at night. Responsive: We pride ourselves on our rapid response to clients. Experienced: A proven legal expert will work directly with you. TOP FOOD AND DRUG CASES 2020 AND CASES TO WATCH 2021 Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular AnnualConference.
KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policySARA W. KOBLITZ
Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. D.C. CIRCUIT CORRECTS FDA’S ABUSE OF DISCRETION IN DRUG … Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes. But, in Genus Med. Techs., LLC v.United States FDA, 2021 U.S. App. LEXIS 10928, 994 F.3d 631 (D.C. Cir. 2021), the U.S. Court of Appeals for the District of Columbia Circuit decided that the Food and Drug Administration had taken that leeway too far.DARA KATCHER LEVY
Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications, marketing, and import/export. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the pre-marketing stage, Dara worksJEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
DAVID B. CLISSOLD
David B. Clissold has broad-based experience advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.RIËTTE VAN LAACK
Ms. van Laack has advanced degrees in Nutrition and Meat Science, and more than 15 years experience in food research. Ms. van Laack was a professor at the Department of Food Science and Technology at the University of Tennessee. While in law school, Ms. van Laack was an Articles Editor of the Tennessee Law Review. Practice Areas. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyMARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.KARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDAFRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsGAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyMARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.KARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDAFRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsGAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.ABOUT US - HPM
Why you’ll like working with us. Smart and committed: We care about the issues you care about, and we devote our resources to finding answers to the questions that keep you up at night. Responsive: We pride ourselves on our rapid response to clients. Experienced: A proven legal expert will work directly with you.CONTACT US - HPM
Driving Directions For driving directions from any point to our D.C. office, please access directions from MapQuest®. Map of 700 13th St Nw Washington, DC 20005-3960, US TOP FOOD AND DRUG CASES 2020 AND CASES TO WATCH 2021 Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular AnnualConference.
FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
D.C. CIRCUIT CORRECTS FDA’S ABUSE OF DISCRETION IN DRUG … Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes. But, in Genus Med. Techs., LLC v.United States FDA, 2021 U.S. App. LEXIS 10928, 994 F.3d 631 (D.C. Cir. 2021), the U.S. Court of Appeals for the District of Columbia Circuit decided that the Food and Drug Administration had taken that leeway too far.JEFFREY N. GIBBS
Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, including regulatory strategy, product approvals, advertising and promotion, appeals, citizen petitions, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medicaldevice
MARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.GAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.DAVID B. CLISSOLD
David B. Clissold has broad-based experience advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyKARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDAFRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
TRANSFER OWNERSHIP OF 510(K) CLEARANCE any medical devices require 510(k) clear-ance or premarket application (PMA) approval from FDA prior to commercial distribution. A firm thatis purchasing or
HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.KARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyKARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDAFRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
TRANSFER OWNERSHIP OF 510(K) CLEARANCE any medical devices require 510(k) clear-ance or premarket application (PMA) approval from FDA prior to commercial distribution. A firm thatis purchasing or
ABOUT US - HPM
Why you’ll like working with us. Smart and committed: We care about the issues you care about, and we devote our resources to finding answers to the questions that keep you up at night. Responsive: We pride ourselves on our rapid response to clients. Experienced: A proven legal expert will work directly with you.CONTACT US - HPM
Driving Directions For driving directions from any point to our D.C. office, please access directions from MapQuest®. Map of 700 13th St Nw Washington, DC 20005-3960, US FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
TOP FOOD AND DRUG CASES 2020 AND CASES TO WATCH 2021 Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in conjunction with its popular AnnualConference.
D.C. CIRCUIT CORRECTS FDA’S ABUSE OF DISCRETION IN DRUG … Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes. But, in Genus Med. Techs., LLC v.United States FDA, 2021 U.S. App. LEXIS 10928, 994 F.3d 631 (D.C. Cir. 2021), the U.S. Court of Appeals for the District of Columbia Circuit decided that the Food and Drug Administration had taken that leeway too far.JEFFREY N. GIBBS
Jeffrey N. Gibbs joined Hyman, Phelps & McNamara in 1990. Over the course of his career, he has developed an extensive knowledge of FDA law, including regulatory strategy, product approvals, advertising and promotion, appeals, citizen petitions, and enforcement actions. In recent years, Mr. Gibbs has focused primarily on advising medicaldevice
MARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.GAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.LARRY J. BAUER
Larry Bauer provides counsel to drug manufacturers on a wide range of regulatory topics including Rare Pediatric Disease Designation requests, Orphan Drug Designation requests, Fast Track and Breakthrough Therapy Designation requests, drug development regulatory strategy, preparing regulatory submissions, and drafting regulatory policies and procedures.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US Expertise in all things FDA. Your company has been presented with a new opportunity—going public, acquiring a business, merging, or another new business relationship.PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases.KARIN F.R. MOORE
Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude ofGAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.KARLA L. PALMER
Provides counsel on DEA registration matters, investigations, and enforcement actions to registrants throughout the drug supply chain. Advises on the regulation of listed chemicals, including pre-cursor ingredients used in the manufacture of controlled substances. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.JAMES E. VALENTINE
James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT US Expertise in all things FDA. Your company has been presented with a new opportunity—going public, acquiring a business, merging, or another new business relationship.PROFESSIONALS
Expertise in all things FDA. Menu. MenuKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases.KARIN F.R. MOORE
Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude ofGAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.KARLA L. PALMER
Provides counsel on DEA registration matters, investigations, and enforcement actions to registrants throughout the drug supply chain. Advises on the regulation of listed chemicals, including pre-cursor ingredients used in the manufacture of controlled substances. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.JAMES E. VALENTINE
James Valentine assists medical product industry and patient advocacy organization clients in a wide range of regulatory matters, including new drug and biologic development and approval issues.PUBLICATIONS
Appeals Court Finds Right to Post-Phase I Investigational New Drugs; Makes Controversial Comments about Off-Label Use and Promotion May 5th, 2006. On May 2, 2006, the United States Court of Appeals for the District of Columbia Circuit concluded in a two-to-one ruling that mentally competent, terminally ill adult patients have the right to obtain potentially life-saving investigational newKARIN F.R. MOORE
Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude ofIVD/LDT - HPM
In vitro diagnostic assays (IVDs) are some of the most complex regulated (and in some cases unregulated) devices on the market today. IVD manufacturers and laboratories running these tests need attorneys with specialized knowledge to understand the complicated and evolving regulatory framework of FDA regulation, CLIA, and state licensure.MICHAEL S. HEESTERS
Michael Heesters is a trial attorney, former Assistant United States Attorney and pharmacist. Mr. Heesters has served as a first-chair litigator and has direct experience with government investigations involving agencies, such as FDA, DEA and HHS.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
SARA W. KOBLITZ
Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book.LARRY J. BAUER
Larry Bauer provides counsel to drug manufacturers on a wide range of regulatory topics including Rare Pediatric Disease Designation requests, Orphan Drug Designation requests, Fast Track and Breakthrough Therapy Designation requests, drug development regulatory strategy, preparing regulatory submissions, and drafting regulatory policies and procedures.DAVID B. CLISSOLD
David B. Clissold has broad-based experience advising pharmaceutical, biotechnology, medical device, food, and dietary supplement clients on regulatory and legislative matters.ROGER C. THIES
Prior to joining the firm in 1988, Mr. Thies was Vice President and General Counsel of G.D. Searle & Co. He joined Searle in 1970 as a staff attorney, counselingDARA KATCHER LEVY
Advertising and Promotion. Advises clients on requirements pertaining to labeling and advertising claims in print and electronic/social media. Serves as the legal and regulatory reviewer on product promotional review committees, assisting with new product launches and ongoing brand management. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT USHYMAN PHELPS MCNAMARAHYMAN PHELPS AND MCNAMARA PCHYMAN PHELPS FDA HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
MARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsMCKENZIE E. CATO
McKenzie E. Cato assists clients with pre- and post-market FDA regulatory topics, including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, and reviewing advertising and promotional materials.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT USHYMAN PHELPS MCNAMARAHYMAN PHELPS AND MCNAMARA PCHYMAN PHELPS FDA HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
MARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsMCKENZIE E. CATO
McKenzie E. Cato assists clients with pre- and post-market FDA regulatory topics, including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, and reviewing advertising and promotional materials.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.ABOUT US - HPM
Why you’ll like working with us. Smart and committed: We care about the issues you care about, and we devote our resources to finding answers to the questions that keep you up at night. Responsive: We pride ourselves on our rapid response to clients. Experienced: A proven legal expert will work directly with you.CONTACT US - HPM
Driving Directions For driving directions from any point to our D.C. office, please access directions from MapQuest®. Map of 700 13th St Nw Washington, DC 20005-3960, US FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
KURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.ANNE K. WALSH
Anne K. Walsh | Hyman, Phelps & McNamara, P.C. Overview. With more than 23 years of experience working with the pharmaceutical and medical device industries, Ms. Walsh brings FDA regulatory expertise to clients seeking to achieve their business objectives. She regularly counsels clients facing FDA administrative actions like inspectionsKARLA L. PALMER
Overview. With 25 years’ experience as a litigator, Karla Palmer’s focus at Hyman Phelps is on DEA and FDA enforcement and litigation matters. Ms. Palmer advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDAMARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.SARA W. KOBLITZ
Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book.GAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT USHYMAN PHELPS MCNAMARAHYMAN PHELPS AND MCNAMARA PCHYMAN PHELPS FDA Expertise in all things FDA. Your company has been presented with a new opportunity—going public, acquiring a business, merging, or another new business relationship.PROFESSIONALS
Expertise in all things FDA. Menu. MenuKARIN F.R. MOORE
Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude ofKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
MCKENZIE E. CATO
McKenzie E. Cato assists clients with pre- and post-market FDA regulatory topics, including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, and reviewing advertising and promotional materials.GAIL H. JAVITT
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters.MARK I. SCHWARTZ
Director’s Distinguished Service Award as a member of the team that reviewed the applications for the vaccines Trumenba and Bexsero. Commissioner’s Award of Excellence for providing excellent legal counsel to high level agency officials on a wide range of complex and significant matters involving biological products. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements. HYMAN, PHELPS & MCNAMARA, P.C.PRACTICESINDUSTRIESFDA REGULATORY CATEGORIESPROFESSIONALSABOUT USCONTACT USHYMAN PHELPS MCNAMARAHYMAN PHELPS AND MCNAMARA PCHYMAN PHELPS FDA HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliancepractice.
PROFESSIONALS
Expertise in all things FDA. Menu. MenuKARIN F.R. MOORE
Karin F.R. Moore | Hyman, Phelps & McNamara, P.C. Overview. Drawing on her years of experience as a former general counsel to leading trade associations, Karin Moore is an industry expert and thought leader who can anticipate issues and mitigate the multitude of risks to clients. She counsels and advocates on a broad range of regulatory, policyKURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
MARK I. SCHWARTZ
Overview. Mr. Schwartz advises clients on drug, biologic and device compliance, chemistry, manufacturing and control issues, combination product issues, and has served as an expert witness in FDA-related litigation. He joined the firm after spending close to 13 years at the Food and Drug Administration in various capacities.FRANK J. SASINOWSKI
Frank J. Sasinowski, M.S., M.P.H., J.D., by assisting sponsors and patient organizations in developing new medicines, has helped secure FDA approval for hundreds of new drugs, including more than 100 new molecular entities, often for serious and rare diseases. Frank was involved in 6 of the most recent 8 drugs FDA approved by way of itsMCKENZIE E. CATO
McKenzie E. Cato assists clients with pre- and post-market FDA regulatory topics, including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, and reviewing advertising and promotional materials.ADRIENNE R. LENZ
Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing advertising and promotional materials, and addressing enforcement matters. DEBORAH L. LIVORNESE Ms. Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements.CONTACT US - HPM
Driving Directions For driving directions from any point to our D.C. office, please access directions from MapQuest®. Map of 700 13th St Nw Washington, DC 20005-3960, USPUBLICATIONS
Appeals Court Finds Right to Post-Phase I Investigational New Drugs; Makes Controversial Comments about Off-Label Use and Promotion May 5th, 2006. On May 2, 2006, the United States Court of Appeals for the District of Columbia Circuit concluded in a two-to-one ruling that mentally competent, terminally ill adult patients have the right to obtain potentially life-saving investigational newPUBLICATIONS
The Problem of the ‘Intended Use’ Regulations Continues to Fester March 21st, 2017. In 2015, FDA proposed revising the so-called A1:I298 use regulation (21 CFR 201.128; id. § 801.4) to remove the famous ‘knowledge’ sentence: But if a manufacturer knows, or has knowledge of facts that would give him notice, that a introduced into interstate commerce FDA REGULATORY CATEGORIES FDA Regulatory Categories If FDA covers you, we've got you covered. Drugs & Biologics. Biosimilars; Combination Products; Compounded DrugProducts
KURT R. KARST
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. DEBORAH LIVORNESE IS SPEAKING AT FDLI’S REGENERATIVE Deborah Livornese is speaking at FDLI’s Regenerative Medicine: Regulatory, Legal, and Compliance Challenges for Cell and Gene Therapies ConferenceANNE K. WALSH
Successful Outcomes in Government Investigations. Settlement of a False Claims Act suit at an amount that was a 10-fold decrease from the government’s initial demand, on behalf of a contract manufacturer of medical devices marketing surgical instruments withoutFDA approval.
SARA W. KOBLITZ
Sara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book.KARLA L. PALMER
Provides counsel on DEA registration matters, investigations, and enforcement actions to registrants throughout the drug supply chain. Advises on the regulation of listed chemicals, including pre-cursor ingredients used in the manufacture of controlled substances.JEFFREY K. SHAPIRO
Jeffrey K. Shapiro specializes in medical device law, advising and representing companies before FDA for more than 25 years. He has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s andwarning letters.
Not all opportunities are equal Your company has been presented with a new opportunity—going public, acquiring a business, merging, or another new business relationship. We can help. Our team has the expertise to help you assess the risks and benefits of this potential endeavor. HPM has deep experience in a wide variety of corporate and transactional matters as they relate to FDA, DEA, and USDA. learn about our Due Diligence & Transactions practice The finish line is only the beginning You’ve worked hard to bring your product to market and the journey has just begun. Realizing your return on investment requires a successful product launch and ongoing promotion while meeting your regulatory obligations. Not an easy task. We’ve been there and we’re here to help. learn about our Product Development & Authorization practice Right there, when you need us most You find yourself the recipient of an indictment, complaint or a show cause order. Maybe you are compelled to take the offensive against a competitor’s unlawful practices or an agency’s arbitrary finalaction.
learn about our Enforcement & Litigation practice Because getting it right is not optional You’ve spent years developing a game-changing product. Before you shake up the industry, you need to begin production in compliance with cGMPs. HPM helps companies from beginning to end with cGMP and quality system compliance matters. Whether it’s a small company just getting started or a large manufacturing operation experiencing quality challenges, HPM has the right expertise to help establish & review cGMP-compliant systems and processes. learn about our Compliance practice Expertise in all things FDAMenu
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