From The British Medical Journal – “The decline of science at the FDA has become unmanageable”
âBefore 1962, US federal law did not require pre-marketing proof of effectiveness for drugs. But senate hearings revealing widespread false advertising of drugsâalong with the thalidomide safety disasterâspurred Congress into action. From then on, approval of a New Drug Application (NDA) by the US Food and Drug Administration required proof of âsubstantial evidenceâ of effectiveness. … Read more