DVD - single user: FDA, A History

March 2013

Remember your first day on the job as a regulatory affairs professional? The new co-workers, new surroundings and responsibilities, the desire to master your new assignments? Plus all the new industry jargon: GMPs, NDAs, INDs, QC, QA and of course, the granddaddy of them all: the FDA.

To a new employee — and even some veterans — the FDA is a mystery: Part cop, part scientist and part politician. But it’s the most important agency you, as a newcomer to the industry, will ever deal with. Wouldn’t it be a good idea to know how the agency really works?

With Each DVD
You’ll Get:

  • 1-hour and 15-Minute Training DVD
  • Discussion Leader Guide to FDA: a History
  • Knowledge Assessment
  • Knowledge Assessment Answer Key

Working with the FDA can be incredibly frustrating, as you try to figure out, which hat the agency is wearing today: Legal rulemaker? Promoter of new medicines? Protector of consumer safety? It can seem like the agency’s conflicting roles make it impossible to understand. But once you know how the agency started and how it evolved, you’ll understand how its mission has evolved into the FDA we know today.  

Divided into eight episodes, FDA: A History is shot in the familiar documentary style made famous by Ken Burns. Entertaining as it informs, it can be watched in one sitting, or as a series of episodes, to foster discussion and analysis.

FDA: A History tells the story from its inception in the latter part of the 1800s through the present day. Illustrated with original images and never-before-aired footage, the story is told by those who know the FDA best — investigators, historians, authors and employees at all levels of the organization.

The documentary includes interviews with: Donald Kennedy (former commissioner of the FDA), Peter Barton Hutt (former General Counsel for the FDA), John Villforth and Kathyrn Zoon (former heads of FDA centers), Suzanne White Junod and John Swann (FDA Historians), authors Philip Hilts, Marion Nestle, Daniel Carpenter, FDA investigators and others.

Episode Guide

  • Pre-1906 – Caveat Emptor
  • After 1906: Enforcing the New Law – Inspectors and Court Cases
  • 1927: The Food, Drug and Insecticide Administration
  • 1938: the Food Drug and Cosmetic Act – Science and Law
  • 1950s: The Birth of an Industry
  • After 1962: Good Practices
  • 1980s and 90s – Government – Part of the solution. Part of the Problem
  • 2000: FDA for a New Millennium

FDA: A History is offered in DVD format.