Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016

Beatrice L Brown; Mayookha Mitra-Majumdar; Jonathan J Darrow; Osman Moneer; Catherine Pham; Jerry Avorn; Aaron S Kesselheim

doi:10.1001/jamainternmed.2022.4226

Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016

JAMA Intern Med. 2022 Oct 3;182(11):1223-1226. doi: 10.1001/jamainternmed.2022.4226. Online ahead of print.

Authors

Beatrice L Brown¹, Mayookha Mitra-Majumdar¹, Jonathan J Darrow¹, Osman Moneer², Catherine Pham³, Jerry Avorn¹, Aaron S Kesselheim¹

Affiliations

¹ Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
² Yale School of Medicine, New Haven, Connecticut.
³ Kaiser Permanente National Pharmacy, Downey, California.

No abstract available

Plain language summary

This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements.