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Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.
Brown, Beatrice L; Mitra-Majumdar, Mayookha; Darrow, Jonathan J; Moneer, Osman; Pham, Catherine; Avorn, Jerry; Kesselheim, Aaron S.
Affiliation
  • Brown BL; 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.
  • Mitra-Majumdar M; 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.
  • Darrow JJ; 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.
  • Moneer O; Yale School of Medicine, New Haven, Connecticut.
  • Pham C; Kaiser Permanente National Pharmacy, Downey, California.
  • Avorn J; 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.
  • Kesselheim AS; 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.
JAMA Intern Med ; 2022 Oct 03.
Article in En | MEDLINE | ID: mdl-36190713
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.
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Full text: 1 Database: MEDLINE Type of study: Observational_studies Language: En Year: 2022 Type: Article
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Full text: 1 Database: MEDLINE Type of study: Observational_studies Language: En Year: 2022 Type: Article