Literature DB >> 29801111

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

Marjorie Zettler1, Chadi Nabhan1.   

Abstract

Mesh:

Year:  2018        PMID: 29801111      PMCID: PMC6145721          DOI: 10.1001/jamaoncol.2018.0610

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


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  2 in total

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

Authors:  Anupam B Jena; Jie Zhang; Darius N Lakdawalla
Journal:  JAMA Oncol       Date:  2017-11-01       Impact factor: 31.777

2.  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

  2 in total
  5 in total

1.  Association Between FDA Label Restriction and Immunotherapy and Chemotherapy Use in Bladder Cancer.

Authors:  Ravi B Parikh; Blythe J S Adamson; Sean Khozin; Matthew D Galsky; Shrujal S Baxi; Aaron Cohen; Ronac Mamtani
Journal:  JAMA       Date:  2019-09-24       Impact factor: 56.272

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.  Extended Application of Genomic Selection to Screen Multi-Omics Data for the Development of Novel Pyroptosis-Immune Signatures and Predicting Immunotherapy of Glioma.

Authors:  Shuai Ma; Fang Wang; Nan Wang; Jiaqi Jin; Xiuwei Yan; Lili Wang; Xiangrong Zheng; Shaoshan Hu; Jianyang Du
Journal:  Front Pharmacol       Date:  2022-05-10       Impact factor: 5.988

4.  Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe.

Authors:  Rick A Vreman; Huseyin Naci; Wim G Goettsch; Aukje K Mantel-Teeuwisse; Sebastian G Schneeweiss; Hubert G M Leufkens; Aaron S Kesselheim
Journal:  Clin Pharmacol Ther       Date:  2020-04-20       Impact factor: 6.875

5.  The frequency of medical reversals in a cross-sectional analysis of high-impact oncology journals, 2009-2018.

Authors:  Alyson Haslam; Jennifer Gill; Tyler Crain; Diana Herrera-Perez; Emerson Y Chen; Talal Hilal; Myung S Kim; Vinay Prasad
Journal:  BMC Cancer       Date:  2021-08-03       Impact factor: 4.430

  5 in total

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