Literature DB >> 30543020

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

Joshua D Wallach1,2,3, Alexander C Egilman4,5, Joseph S Ross5,6,7,8, Steven Woloshin9, Lisa M Schwartz9.   

Abstract

Year:  2019        PMID： 30543020      PMCID： PMC6445841          DOI： 10.1007/s11606-018-4779-x

Source DB:  PubMed          Journal:  J Gen Intern Med        ISSN： 0884-8734            Impact factor:   5.128


× No keyword cloud information.
  4 in total

1.  A lifecycle approach to the evaluation of FDA approval methods and regulatory actions: opportunities provided by a new IOM report.

Authors:  Bruce M Psaty; Eric M Meslin; Alasdair Breckenridge
Journal:  JAMA       Date:  2012-06-20       Impact factor: 56.272

2.  Publication and Reporting of the Results of Postmarket Studies for Drugs Required by the US Food and Drug Administration, 2009 to 2013.

Authors:  Marisa L Cruz; Jing Xu; Mwango Kashoki; Peter Lurie
Journal:  JAMA Intern Med       Date:  2017-08-01       Impact factor: 21.873

3.  The Fate of FDA Postapproval Studies.

Authors:  Steven Woloshin; Lisa M Schwartz; Brian White; Thomas J Moore
Journal:  N Engl J Med       Date:  2017-09-21       Impact factor: 91.245

4.  Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.

Authors:  Joshua D Wallach; Alexander C Egilman; Sanket S Dhruva; Margaret E McCarthy; Jennifer E Miller; Steven Woloshin; Lisa M Schwartz; Joseph S Ross
Journal:  BMJ       Date:  2018-05-24
  4 in total
  9 in total

1.  Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.

Authors:  Sanket S Dhruva; Jonathan J Darrow; Aaron S Kesselheim; Rita F Redberg
Journal:  J Gen Intern Med       Date:  2022-02-09       Impact factor: 5.128

2.  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

3.  Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.

Authors:  Joshua J Skydel; Alexander C Egilman; Joshua D Wallach; Reshma Ramachandran; Ravi Gupta; Joseph S Ross
Journal:  JAMA Health Forum       Date:  2022-05-27

4.  Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020.

Authors:  Mayookha Mitra-Majumdar; Simon J Gunter; Aaron S Kesselheim; Beatrice L Brown; Krysten W Joyce; Murray Ross; Catherine Pham; Jerry Avorn; Jonathan J Darrow
Journal:  JAMA Netw Open       Date:  2022-05-02

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

6.  Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis.

Authors:  Joshua D Wallach; Anita T Luxkaranayagam; Sanket S Dhruva; Jennifer E Miller; Joseph S Ross
Journal:  BMC Med       Date:  2019-06-17       Impact factor: 8.775

7.  Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018.

Authors:  Joshua D Wallach; Reshma Ramachandran; Till Bruckner; Joseph S Ross
Journal:  JAMA Netw Open       Date:  2021-11-01

8.  Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.

Authors:  Joshua D Wallach; Audrey D Zhang; Joshua J Skydel; Victoria L Bartlett; Sanket S Dhruva; Nilay D Shah; Joseph S Ross
Journal:  JAMA Netw Open       Date:  2021-11-01

9.  Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.

Authors:  Avi Cherla; Elias Mossialos; Maximilian Salcher-Konrad; Aaron S Kesselheim; Huseyin Naci
Journal:  Clin Pharmacol Ther       Date:  2022-06-23       Impact factor: 6.903
  9 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.