The FDA recently launched an excellent Web site with detailed background on the drug-approval process. From the FDA press release:

The information includes:

• Drug Approval Application Process
  An overview from test tube to marketing

• Investigational New Drugs
  Includes emergency INDs, FAQs, etc.

• New Drug Applications

• Generic Drug Applications

• Electronic Submissions

• Small Business Assistance Program
  Includes funding sources and orphan drugs

• Post Drug Approval Activities
  Includes advertising, medication errors, drug shortages and surveillance activities

Treatment activist Brenda Lein of Project Inform said, "The information is absolutely wonderful and I'd encourage any treatment activist who isn't clear about the FDA and their process to read through the materials and become familiar with the drug discovery and development process... [including] why companies conduct certain tests based on what the FDA requires of them, and why other tests may not be conducted."

The FDA site is at http://www.fda.gov/cder/regulatory/applications/default.htm.

ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.

Back to the AIDS Treatment News March 17, 2000 contents page.