FDA Regulation Needs to Catch Up to Modern Medicine

No drug may be licensed until the FDA is convinced that it will perform safely and effectively in future patients. All such predictions hinge, of course, on both the drug's chemistry and the patient's; pharmacology is not a science of one hand clapping. So the FDA does not license drugsā€”it licenses specified drug-patient combinations: the license's implicit promise of future safety and efficacy applies only "under the conditions of use prescribed, recommended, or suggested in the labeling thereof."

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