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La aprobación de la FDA y la regulación de los productos farmacéuticos, 1983-2018

Jonathan J Darrow1, Jerry Avorn1, Aaron S Kesselheim1

  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

JAMA
|January 15, 2020
PubMed
Resumen

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) ha simplificado los procesos de aprobación de medicamentos desde la década de 1980, aumentando las aprobaciones de medicamentos y utilizando programas acelerados. Las tarifas de los usuarios financian significativamente las operaciones de la FDA, lo que permite revisiones más rápidas y un mayor acceso a los medicamentos.

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