Where can I find information about the FDA approval process of drugs, medicine, pharmacological agents?

Question

I need to present information on how medicines become approved for use by the FDA. I also could use info on the authority of the FDA and how politics influence it. The steps required for a drug to get approval, regulation of drugs and advertising, etc. Any ideas on good sources for me to look at?

Answer 1

Here's a diagram of the process http://www.fda.gov/cder/handbook/develop.htm

Here's a detailed review of the drug approval application process
http://www.fda.gov/cder/regulatory/applications/

As for politics, look up information about the OTC status application for emergency contraception. It's a very interesting but sad history. You can then compare that to the quick approval of Viagra.

Let me know if you need any more help. :)

Answer 2

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