FDA Drug-Approval Background: New Web Pages

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