Hatch-Waxman Act of 1984

Legislation / Policy

A landmark US law that created a streamlined pathway for generic drugs at the FDA, waiving the need for generics to repeat full clinical trials but requiring bioequivalence, and introducing a 'first-to-file' exclusivity incentive.

Mentioned in 1 video

Videos Mentioning Hatch-Waxman Act of 1984

#71 – Katherine Eban: Widespread fraud in the generic drug industry

#71 – Katherine Eban: Widespread fraud in the generic drug industry

Peter Attia MD

A landmark US law that created a streamlined pathway for generic drugs at the FDA, waiving the need for generics to repeat full clinical trials but requiring bioequivalence, and introducing a 'first-to-file' exclusivity incentive.