Literature DB >> 34254981

Fulfilling the Mandate of the US Food and Drug Administration's Accelerated Approval Pathway: The Need for Reforms.

Bishal Gyawali1, Joseph S Ross2, Aaron S Kesselheim3.   

Abstract

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Year:  2021        PMID： 34254981     DOI： 10.1001/jamainternmed.2021.4604

Source DB:  PubMed          Journal:  JAMA Intern Med        ISSN： 2168-6106            Impact factor:   21.873


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  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

Review 2.  Role of Aducanumab in the Treatment of Alzheimer's Disease: Challenges and Opportunities.

Authors:  Miguel Vaz; Vítor Silva; Cristina Monteiro; Samuel Silvestre
Journal:  Clin Interv Aging       Date:  2022-05-18       Impact factor: 3.829

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

Review 4.  FDA Drug Approval and the Ethics of Desperation.

Authors:  Emily A Largent; Andrew Peterson; Holly Fernandez Lynch
Journal:  JAMA Intern Med       Date:  2021-12-01       Impact factor: 21.873

5.  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

6.  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

Review 7.  [Disease-modifying treatment approaches for Alzheimer's disease].

Authors:  Lutz Frölich; Lucrezia Hausner
Journal:  Nervenarzt       Date:  2021-11-04       Impact factor: 1.297

8.  Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019.

Authors:  Kerstin N Vokinger; Thomas J Hwang; Camille E G Glaus; Aaron S Kesselheim
Journal:  JAMA Netw Open       Date:  2022-04-01

9.  Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.

Authors:  Kerstin N Vokinger; Aaron S Kesselheim; Camille E G Glaus; Thomas J Hwang
Journal:  JAMA Health Forum       Date:  2022-08-05
  9 in total

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