Literature DB >> 28930510

The Fate of FDA Postapproval Studies.

Steven Woloshin1, Lisa M Schwartz1, Brian White1, Thomas J Moore1.   

Abstract

Mesh：

Year:  2017        PMID： 28930510     DOI： 10.1056/NEJMp1705800

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  22 in total

1.  Timeliness of Postmarket Studies for New Pharmaceuticals Approved Between 2009 and 2012: a Cross-Sectional Analysis.

Authors:  Joshua D Wallach; Alexander C Egilman; Joseph S Ross; Steven Woloshin; Lisa M Schwartz
Journal:  J Gen Intern Med       Date:  2019-04       Impact factor: 5.128

2.  Conditional power as an aid in making interim decisions in observational studies.

Authors:  Alexander Muir Walker
Journal:  Eur J Epidemiol       Date:  2018-05-28       Impact factor: 8.082

3.  Fulfillment of Postmarketing Requirements to the FDA for Therapies Granted Oncology Indications Between 2011 and 2016.

Authors:  Marjorie Zettler; Chadi Nabhan
Journal:  JAMA Oncol       Date:  2018-07-01       Impact factor: 31.777

4.  Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

Authors:  Thomas J Hwang; Liat Orenstein; Aaron S Kesselheim; Florence T Bourgeois
Journal:  JAMA Pediatr       Date:  2019-01-01       Impact factor: 16.193

5.  To stop or not to stop: a value of information view.

Authors:  Uwe Siebert; Lára R Hallsson
Journal:  Eur J Epidemiol       Date:  2018-08-17       Impact factor: 8.082

6.  Clinical Usage of the Adjuvanted Herpes Zoster Subunit Vaccine (HZ/su): Revaccination of Recipients of Live Attenuated Zoster Vaccine and Coadministration With a Seasonal Influenza Vaccine.

Authors:  Michael N Oxman; Ruth Harbecke; David M Koelle
Journal:  J Infect Dis       Date:  2017-12-12       Impact factor: 5.226

7.  Accelerated approval of medicines: fit for purpose?

Authors:  Alasdair Breckenridge; Lawrence Liberti
Journal:  Nat Rev Drug Discov       Date:  2018-01-05       Impact factor: 84.694

8.  Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

Authors:  Jeremy M O'Connor; Kristen L Fessele; Jean Steiner; Kathi Seidl-Rathkopf; Kenneth R Carson; Nathan C Nussbaum; Emily S Yin; Kerin B Adelson; Carolyn J Presley; Anne C Chiang; Joseph S Ross; Amy P Abernethy; Cary P Gross
Journal:  JAMA Oncol       Date:  2018-08-09       Impact factor: 31.777

9.  The Prescription Drug User Fee Act: Much More Than User Fees.

Authors:  Aaron P Mitchell; Niti U Trivedi; Peter B Bach
Journal:  Med Care       Date:  2022-04-01       Impact factor: 2.983

10.  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
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