With backgrounds in pharmacy and law, and 14 years of regulatory experience at the Food and Drug Administration (FDA), clients rely on David Rosen鈥檚 nearly five decades of knowledge when seeking strategic guidance on FDA submissions, compliance, advertising, and enforcement.
A partner and public policy lawyer with 麻豆传媒 in the firm鈥檚 Washington, D.C. office, David has extensive experience in health law, life sciences, and food and drug regulation, including a range of FDA regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices, and biologics. He is the firm鈥檚 FDA Practice Group leader, and member of the Government Solutions Practice Group, the Cannabis and Food & Beverage Industries, and the Health Care & Life Sciences and Telemedicine Sectors.
At FDA, David progressed to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues, and related compliance activities. He authored the FDA鈥檚 Orange Book (Approved Drug Products With Therapeutic Equivalence Evaluations), which identifies drug products approved by FDA on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act; and was instrumental to the development and implementation of the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act), as well as FDA鈥檚 Accelerated Approval regulations for new drugs. He utilizes this insider perspective to assist clients within all FDA-regulated industries respond to warning letters and FDA 483 observations, write FDA meeting requests for pre-IND and 505(b)(2) products, and interact with FDA to facilitate product review and approval. He is a recognized leader in virtually all aspects related to the drug and medical device approval/clearance processes, combination products, and jurisdictional issues.
David frequently speaks before national and international pharmaceutical industry associations on the ANDA submission and review process and on the IND and expedited drug development, review, and approval processes. He has presented before investment analysts and managers of venture capital on the impact of FDA on the drug and biotech industry.
David was formerly a partner at two other major law firms where he was a member and leader of the FDA and life sciences practices.
Awards and Recognition
- IP Star, Managing Intellectual Property magazine (2015-2016, 2025)
- Winner – Food, Drugs, Healthcare, Life Sciences in Mondaq’s Autumn 2024 Thought Leadership Awards
- Peer review rated as AV Preeminent庐, the highest performance rating in the Martindale-Hubbell庐 Peer Review Ratings鈩 system
- The Best Lawyers in America庐 鈥 FDA Law (2021-2026)
- The Legal 500 鈥 Life Sciences (2012-2016)
Affiliations
- Emeritus member, University of Connecticut School of Pharmacy Advisory Board
Presentations and Publications
- Co-author, “Texas Court Vacates FDA鈥檚 Laboratory Developed Test (LDT) Final Rule,” Health Care Law Today (April 2, 2025)
- Co-author, 鈥淐ompounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA鈥檚 Declaration that Tirzepatide Shortage is Resolved; Plaintiff OFA Appeals,鈥 Health Care Law Today (March 12, 2025)
- Co-author, 鈥淕LP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List,鈥 Health Care Law Today (February 25, 2025)
- Co-author, “GLP-1 Drugs: FDA 鈥淩e-Confirms鈥 Decision Removing Tirzepatide from the Drug Shortage List,” Health Care Law Today (December 20, 2024)
- Co-author, “FDA Targets GLP-1 Providers with Warning Letters,” Health Care Law Today (December 18, 2024)
- Co-Author, “GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding,” Health Care Law Today (December 2, 2024)
- Co-Presenter, “GLP-1 Drugs: What’s Next after FDA’s Resolution of Drug Shortages,” 麻豆传媒 & Lardner Webinar (December 4, 2024)
- Co-Author, “GLP-1 Drugs: FDA Sued Over Removing Tirzepatide from the Drug Shortage List,” Health Care Law Today (October 23, 2024)
- Co-Author, “GLP-1 Drugs: FDA Removes Lilly鈥檚 Zepbound庐 and Mounjaro庐 (tirzepatide injection) from its Drug Shortage List,” Health Care Law Today (October 7, 2024)
- Author, 鈥淜eeping Track of Your Data 鈥 What You Need to Know about FDA鈥檚 Draft Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies,鈥 Health Care Law Today (May 15, 2024)
- Speaker, 鈥淔lorida鈥檚 Gamble to Lower Prescription Drug Prices with Canadian Imports: Will Other States Follow or Will It Backfire?,鈥 New York State Bar Association鈥檚 Food, Drug & Cosmetic Law Section 2024 Spring Meeting (April 11, 2024)
- Co-Author, 鈥淗ealth Care & Life Sciences Sector Top Trends for 2023,鈥 Health Care Law Today (Feb. 24, 2023)
- Co-Author, 鈥淢odernization of Cosmetics Regulation Act of 2022: What You Need to Know,鈥 Health Care Law Today (Jan. 25, 2023)
- Co-Author, 鈥淧sychedelic Drugs 鈥 Easing the Regulatory Hurdles for Development,鈥 Health Care Law Today (Dec. 15, 2022)
- Co-Author, 鈥淗earing Aids: More Accessible to Consumers After FDA Issues Final Rule,鈥 Health Care Law Today (Aug. 17, 2022)
- Co-Author, 鈥淥n the Attack: FDA Pursues Online Retail Fulfillment House,鈥 Health Care Law Today (Aug. 16, 2022)
- Co-Author, 鈥淲ill FDA鈥檚 Proposed Ban on Flavored Tobacco Products Ever be Implemented?,鈥 Health Care Law Today (May 26, 2022)
- Co-Author, 鈥淰aping Will Not Make You Well,鈥 Health Care Law Today (Dec. 23, 2021)
- Co-Author, 鈥淭he Proposed Cures 2.0 Act 鈥 What You Can Expect,鈥 Health Care Law Today (Dec. 6, 2021)
- Co-Author, 鈥淚s the DEA Poised to Regulate Telepharmacy?,鈥 Health Care Law Today (Nov. 30, 2021)
- Co-Author, 鈥淩ound Two 鈥 FDA Issues Emergency Use Authorization for Moderna鈥檚 COVID-19 Vaccine,鈥 Coronavirus Resource Center: Back to Business (Dec. 21, 2020)
- Co-Author, 鈥淔DA Issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine,鈥 Coronavirus Resource Center: Back to Business (Dec. 14, 2020)
- Co-Author, 鈥淗istoric FDA Advisory Committee Vote on Pfizer and BioNTech鈥檚 COVID-19 Vaccine,鈥 Coronavirus Resource Center: Back to Business (Dec. 10, 2020)
- Co-Author, 鈥淲hat You Need to Know About President Trump鈥檚 Executive Order to Strengthen the Domestic Supply Chain for Essential Drugs and Medical Devices,鈥 Coronavirus Resource Center: Back to Business (Sept. 8, 2020)
- Co-Author, 鈥淐OVID-19: FDA Issues Template for Over-the-Counter At-Home Testing,鈥 Health Care Law Today (July 30, 2020)
- Co-Author, 鈥淔DA Increases Scrutiny of COVID-19 Serology Tests: What Commercial Manufacturers Need to Know,鈥 Coronavirus Resource Center: Back to Business (May 6, 2020)
- Co-Author, 鈥淔DA Publishes Enforcement Policies to Address Coronavirus Personal Protective Equipment Shortages,鈥 Coronavirus Resource Center: Back to Business (April 6, 2020)
- Co-Author, 鈥淢anaging the Commercial Impact of the Coronavirus: FAQs for the Life Science Industry,鈥 Coronavirus Resource Center: Back to Business (March 17, 2020)
- Co-Author, 鈥淒OJ Issues Guidelines for Enforcement Related to Off-Label Promotion,鈥 Legal News: Government Enforcement Defense & Investigations (March 5, 2018)
FDA to Consider Lifting Restrictions on Numerous Compounded Peptides
David Rosen Weighs in on SCOTUS Review of Skinny Label Patent Dispute
Psychedelics and the Executive Order: From Schedule I to Treatment Priority
David Rosen and William Holtz Analyze FDA Approval Speed, Biotech Pressures
