The decline of science at the FDA has become unmanageable

BMJ

15 May 2023 - Before 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings revealing widespread false advertising of drugs—along with the thalidomide safety disaster—spurred Congress into action. 

From then on, approval of a new drug application by the US FDA required proof of “substantial evidence” of effectiveness.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation