Are you over 18 and want to see adult content?
More Annotations
![A complete backup of sotovikmobile.ru](https://www.archivebay.com/archive2/e0bfc973-a31b-44ff-ade4-d26d3fb12b22.png)
A complete backup of sotovikmobile.ru
Are you over 18 and want to see adult content?
![A complete backup of boultoncenter.org](https://www.archivebay.com/archive2/2ab4768b-4477-4a23-b6f9-fee19d8fd457.png)
A complete backup of boultoncenter.org
Are you over 18 and want to see adult content?
![A complete backup of mountainrailwv.com](https://www.archivebay.com/archive2/a85177fb-433e-4be3-9000-d2ab1de417dd.png)
A complete backup of mountainrailwv.com
Are you over 18 and want to see adult content?
![A complete backup of sportsmansparadiseonline.com](https://www.archivebay.com/archive2/816ea626-e369-4aac-84ba-1b65288140d7.png)
A complete backup of sportsmansparadiseonline.com
Are you over 18 and want to see adult content?
![A complete backup of aignermunich.com](https://www.archivebay.com/archive2/8dcb7deb-b598-407a-a04c-ab1277c72849.png)
A complete backup of aignermunich.com
Are you over 18 and want to see adult content?
![A complete backup of luxurywatch1.myshopify.com](https://www.archivebay.com/archive2/47cc74e3-d5f5-40e1-9cf7-a493a5be6636.png)
A complete backup of luxurywatch1.myshopify.com
Are you over 18 and want to see adult content?
Favourite Annotations
![A complete backup of godae-oceanview.org](https://www.archivebay.com/archive2/1296d8bd-5c70-4576-816e-94d5a012570d.png)
A complete backup of godae-oceanview.org
Are you over 18 and want to see adult content?
![A complete backup of lu5fr.blogspot.com](https://www.archivebay.com/archive2/5ffbc364-f0b8-42f9-ba43-e143f271bba4.png)
A complete backup of lu5fr.blogspot.com
Are you over 18 and want to see adult content?
![A complete backup of portalpravaler.com.br](https://www.archivebay.com/archive2/103f8ce2-b603-41eb-bdaf-c62a44d3e3b7.png)
A complete backup of portalpravaler.com.br
Are you over 18 and want to see adult content?
![A complete backup of beerenobst-erdbeerpflanzen.de](https://www.archivebay.com/archive2/1137ea70-567c-40cc-80cd-1dfffd916fd6.png)
A complete backup of beerenobst-erdbeerpflanzen.de
Are you over 18 and want to see adult content?
Text
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, 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.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
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 FDAGAIL 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. 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.
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.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. We can help you see around that next corner Let us help you envision your product lifecycle. We can help you execute your regulatory and lifecycle management strategies with the coordination, rhythm, and grace necessary for success. Large and small companies alike benefit from help along the way. HPM can guide you through the innumerable regulatory challenges you’ll encounter. learn about our Product Development & Authorization practice When knock, knock is no joke You joined this market to advance health and technologies. Now a government agent is at your door. Whether you work with a small firm or a large distributor, you need experienced help fast. learn about our Enforcement & Litigation 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 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 Expertise in all things FDAMenu
Menu
* Practices
* Industries
* FDA Regulatory Categories* Professionals
* About Us
* Contact Us
* FDA Law Blog
* News & Events
* Search __
* __Twitter
__
FDA Law Blog
News & Events
* __Twitter
* __
* __
* __
* __
* __
* Developments in State Prescription Drug Price Transparency Laws * In Seventeen Years will the Cicadas Around FDA’s White Oak CampusFind…
* Can’t Wait to See You! Will CDER Soon Resume In-Person Meetings? Copyright 2021 Hyman, Phelps & McNamara, P.C.* RDS
* Careers
* Disclaimer
Details
Copyright © 2024 ArchiveBay.com. All rights reserved. Terms of Use | Privacy Policy | DMCA | 2021 | Feedback | Advertising | RSS 2.0