Literature DB >> 36190713

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

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

Abstract

Entities:  

Year:  2022        PMID： 36190713      PMCID： PMC9531062          DOI： 10.1001/jamainternmed.2022.4226

Source DB:  PubMed          Journal:  JAMA Intern Med        ISSN： 2168-6106            Impact factor:   44.409


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  5 in total

1.  The Food and Drug Administration Amendments Act and postmarketing commitments.

Authors:  Kevin Fain; Matthew Daubresse; G Caleb Alexander
Journal:  JAMA       Date:  2013-07-10       Impact factor: 56.272

2.  Development times, clinical testing, postmarket follow-up, and safety risks for the new drugs approved by the US food and drug administration: the class of 2008.

Authors:  Thomas J Moore; Curt D Furberg
Journal:  JAMA Intern Med       Date:  2014-01       Impact factor: 21.873

3.  Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review.

Authors:  Beatrice L Brown; Mayookha Mitra-Majumdar; Krysten Joyce; Murray Ross; Catherine Pham; Jonathan J Darrow; Jerry Avorn; Aaron S Kesselheim
Journal:  J Health Polit Policy Law       Date:  2022-07-14       Impact factor: 2.977

4.  New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.

Authors:  Osman Moneer; Beatrice L Brown; Jerry Avorn; Jonathan J Darrow; Mayookha Mitra-Majumdar; Krysten W Joyce; Murray Ross; Catherine Pham; Aaron S Kesselheim
Journal:  Drug Saf       Date:  2022-02-19       Impact factor: 5.228

5.  US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

Authors:  Joshua J Skydel; Audrey D Zhang; Sanket S Dhruva; Joseph S Ross; Joshua D Wallach
Journal:  Clin Trials       Date:  2021-04-16       Impact factor: 2.486
  5 in total

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