Overview

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. He has extensive experience in health law, life sciences and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

David was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities.

Recognition

  • Peer Review Rated™ as AV Preeminent®, the highest performance rating in the Martindale-Hubbell® Peer Review Ratings™ system
  • Selected by his peers for inclusion in The Best Lawyers in America© in the field of FDA Law (2021)
  • Recognized by The Legal 500 for his work in life sciences (2012-2016)
  • Named an IP Star by Managing Intellectual Property magazine (2015 and 2016)

Thought Leadership

David has been a frequent speaker 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 made presentations before investment analysts and managers of venture capital on the impact of FDA on the drug and biotech industry.

Affiliations

David is a member of the University of Connecticut School of Pharmacy Advisory Board.

Education

  • The Catholic University of America, Columbus School of Law (J.D., 1991)
  • The University of Connecticut School of Pharmacy (B.S., 1978)

Admissions

  • District of Columbia
  • Maryland

Publications

  • “How to Respond to Consent Decrees,” BioPharm International, Vol. 25, Issue 5 (May 1, 2012)
  • “FDA Getting Tougher at the Border,” Pharmaceutical Compliance Monitor (December 14, 2011)
  • “MX: Device Reuse and Safety,” Medical Device and Diagnostic Industry (October 19, 2011)
  • “Next Steps for the U.S. Biosimilar Regulatory Scheme,” Pharmaceutical Technology (March 2011)

Insights

Round Two - FDA Issues Emergency Use Authorization for Moderna’s COVID-19 Vaccine
21 December 2020
Coronavirus Resource Center:Back to Business
FDA Issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine
14 December 2020
Coronavirus Resource Center:Back to Business
Historic FDA Advisory Committee Vote on Pfizer and BioNTech’s COVID -19 Vaccine
10 December 2020
Coronavirus Resource Center:Back to Business
What You Need to Know about President Trump’s Executive Order to Strengthen the Domestic Supply Chain for Essential Drugs and Medical Devices
08 September 2020
Coronavirus Resource Center:Back to Business