Quote:
Originally Posted by Rockstar
“So the FDA does no testing of the drugs they approve”.   |
Well almost. The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.
The drug manufacturers submit their own tests and the CDER reviews the tests for validity and completeness.
If you want to know what the drug company has to submit to the CDER, you can look at Title 21 CFR part 314... But only if you have a lot of time on your hands. The amount of testing data and information that needs to be submitted for CDER review is extensive.
The FDA does not have the charter, authority, budget, nor equipment to independently test new drugs.