David L. Rosen

David L. Rosen

David Rosen is a partner and co-chair of the Life Sciences Industry Team at Foley & Lardner LLP. He is also a member of the firm's Government & Public Policy, and Corporate Compliance & Enforcement Practices and the Health Care, Nanotechnology and Food Industry Teams.

Mr. Rosen 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.

Mr. Rosen 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.

Mr. Rosen's publications include:

· "A Practical Guide to Drug Product Selection: Getting to Know the Food and Drug Administration's (FDA's) Approved Drug Products List (Orange Book) with Therapeutic Equivalence Evaluations," Journal of Pharmacy Practice, Vol. III, No. 3, June 1995

· "The Orange Book - Drug Product Equivalence and Pharmacist Liability," Continuing Education Program for Pharmacists, ABCOMM, Inc., 1997

· "Some Practical Advice on the Interchangeability of Levothyroxine Drug Products and Drug Product Selection," Journal of Pharmacy Practice, Vol. X, No. 5, October 1997

· "The Regulatory Affairs Professional and Device Reform," It's the Law Article, Regulatory Affairs Focus, Vol. 3, Issue 1, January 1998

· "Pharmacy Compounding: The State of the Art and the Law," It's the Law Article, Regulatory Affairs Focus, Vol. 3, Issue 11, November 1998

· "Generic Drug Approval Process: Pre-1984 History Concerning Generic Drugs," The Pharmaceutical Regulatory Process, Vol. 144, 2005

Mr. Rosen 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.

Mr. Rosen earned his J.D. at The Catholic University of America, Columbus School of Law (1991). He also holds a Bachelor of Science degree from the University of Connecticut School of Pharmacy (1978).

Mr. Rosen is admitted to practice in the District of Columbia and Maryland.