Introduction to the FDA’s Regulation of Pharmaceuticals

Production Date: February 23, 2017 Practice Areas: Health Care Law, Science & Technology Law, and Administrative Law Estimated Length: 3658 minutes


$ 59 Health Care Law, Science & Technology Law, and Administrative Law In Stock

The U.S. Food and Drug Administration (“FDA”) regulates pharmaceutical products under a highly complex legal framework intended to ensure that companies market products that are safe and effective. The research and development, manufacturing, approval, labeling, marketing, import and export, and distribution of pharmaceuticals in the United States are regulated primarily under the Federal Food, Drug, and Cosmetic Act (“FDCA”).

The approval requirements under the FDCA and the implementing regulations issued by FDA reflect a careful balance of policy and science that encourages the development of new pharmaceuticals while also providing a pathway for low-cost generic products. Regardless of whether it is a brand-name or generic product, manufacturers must ensure that their products are manufactured in accordance with FDA’s current Good Manufacturing Practice (“cGMP”) requirements, which are enforced through FDA inspections. Often, the regulatory framework governing pharmaceuticals must balance competing tensions, such as FDA’s regulation of pharmaceutical advertising and promotion and a manufacturer’s First Amendment rights.

This course provides an introduction to the regulation of pharmaceuticals by FDA. It reviews approval requirements for brand-name and generic products, advertising and promotion issues, and pharmaceutical manufacturing issues in a global environment. Join Susan Lee, Jim Johnson and Gary Veron, partners in the Pharmaceutical and Biotechnology practice group in the Washington, D.C. office of Hogan Lovells, for this discussion.

Learning Objectives:
  1. Learn about key areas of the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations
  2. Know the regulatory framework governing the approval of brand-name and generic pharmaceutical products

  3. Understand compliance and enforcement risks associated with the manufacturing of pharmaceutical products in a global environment

  4. Grasp the basic tenets of pharmaceutical advertising and promotion

  5. Discuss recent developments in FDA’s regulation of pharmaceuticals

Shelley K.
Gary, IN

An area where I have a lot to learn. Thanks to the presenters for a good introduction.

Gay M.
Sunnyvale, CA


Alexandria K.
Jenkintown, PA

Good course and topic directly related to my work. THANKS!

Diana K.
Oceanside, NY

Good overview. Would like to learn more about clinical trials.

Benjamin S.
Chicago, IL

Thank you!

James B.
New York, NY

Speakers delivered very detailed information in a cogent and understandable way.

Julie A. B.
Hiles, WI

Good grasp of the basics.

Jane E.

Interesting material.

Lisa F.
Oconomowoc, WI

Very interesting course and knowledgeable instructors

Stephen l. K.
Ambler, PA

very well done. covered the salient points!!

William S.
Belmont, NC

A very well done introduction and synopsis. Thank you very much.