Literature DB >> 27684643

The Trade-off Between Speed and Safety in Drug Approvals.

Anupam B Jena1,2,3, Jie Zhang4, Darius N Lakdawalla3,5.   

Abstract

Mesh：

Year:  2017        PMID： 27684643     DOI： 10.1001/jamaoncol.2016.3337

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


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  6 in total

1.  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

2.  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

3.  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

4.  Immune Checkpoint Inhibitor Uptake in Real-World Patients With Malignant Pleural Mesothelioma.

Authors:  Roger Y Kim; Nandita Mitra; Stephen J Bagley; Melina E Marmarelis; Andrew R Haas; Katharine A Rendle; Anil Vachani
Journal:  JTO Clin Res Rep       Date:  2021-05-18

5.  Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

Authors:  Robert Kemp; Vinay Prasad
Journal:  BMC Med       Date:  2017-07-21       Impact factor: 8.775

6.  Tumor organoids to study gastroesophageal cancer: a primer.

Authors:  Ramon U Jin; Jason C Mills
Journal:  J Mol Cell Biol       Date:  2020-08-01       Impact factor: 6.216
  6 in total

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