Regulatory Affairs Role in Product Development

Feb 2020
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Building Value into Biotechnology Development and Manufacturing

The magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to Market, edited by Fred Mermelstein, Richard Prince and Carl Novina and offered electronically. These detailed advisories are written to provide guidance. Here is what Phillip A. Sharp, Ph.D and Nobel Laureate says about this text in his Foreword: "For anyone who wants to excel in biotechnology, this book presents a wonderful guide."

In addition to this reprint, there are more chapters in this comprehensive text that are equally informative in the areas of science, finance, legal and regulatory concerns. For a full text description, table of contents and purchasing details of this unique biotechnology guide and reference please visit:

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Format: PDF (1 file 536 KB)

Table of Contents

Table of Contents:

  • It's the Law: The Why and the How
  • Regulatory Affairs: The Architect, Interpreter and Advocate
  • The Big Pieces: You Can't Get There Without Them
  • Globalization: Dont't Leave Anything on the Table
  • Ready to Launch: Preparing the Beachhead
  • Maintenance: The Party is Just Getting Started
  • References

About the Authors

About the Author

David Rosen BS Pharm, J.D. is a partner and FDA/public policy lawyer with Foley & Lardner LLP inWashington DC.Mr. Rosen 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, biologics, dietary supplements, foods, cosmetics and tobacco products. He is co-chair of the firm's Life Sciences Industry Team, FDA Practice Group Leader and is also a member of the firm's Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was 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 has been Peer Review Rated as AV® Preeminent™, the highest performance rating in Martindale-Hubbell's peer review rating system. In 2012 — 2014, The Legal 500 recognized Mr. Rosen for his work in life sciences. He 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. Mr. Rosen 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 an emeritus member of the University of Connecticut School of Pharmacy Advisory Board.