Literature DB >> 35050302

Accelerated Approval Is Not Conditional Approval: Insights From International Expedited Approval Programs.

Gautam U Mehta1, R Angelo de Claro1,2, Richard Pazdur1,2.   

Abstract

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Year:  2022        PMID： 35050302     DOI： 10.1001/jamaoncol.2021.6854

Source DB:  PubMed          Journal:  JAMA Oncol        ISSN： 2374-2437            Impact factor:   31.777


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  2 in total

1.  Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab.

Authors:  Emily A Largent; Andrew Peterson; Jason Karlawish; Holly Fernandez Lynch
Journal:  Drugs Aging       Date:  2022-06-13       Impact factor: 4.271

2.  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
  2 in total

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