Study: FDA Has ‘No Tradition or Structure to Ensure Consistency’ in Decisions

How should the FDA approach drug approval decisions when the evidence for a product’s efficacy isn’t overwhelming? One place to start would be a rigorous examination of past decisions to bring some consistency and predictability to the process — which the agency currently doesn’t do and couldn’t if it wanted to, researchers said in a blistering critique of the agency’s processes.


Nice paper, yet in light of some 450,000 Americans needlessly killed by pseudoscientific FDA directives, I wish they would have started out with something more like, “You dirty f***king lying bastards are murdering helpless people…” ABN

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