Literature DB >> 29970919

Reinforcing the social compromise of accelerated approval.

Bishal Gyawali1, Aaron S Kesselheim2.   

Abstract

Mesh：

Year:  2018        PMID： 29970919     DOI： 10.1038/s41571-018-0066-3

Source DB:  PubMed          Journal:  Nat Rev Clin Oncol        ISSN： 1759-4774            Impact factor:   66.675


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  5 in total

Review 1.  Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.

Authors:  Bishal Gyawali; Spencer Phillips Hey; Aaron S Kesselheim
Journal:  JAMA Intern Med       Date:  2019-07-01       Impact factor: 21.873

2.  Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness.

Authors:  Melanie McPhail; Emma Weiss; Tania Bubela
Journal:  Front Med (Lausanne)       Date:  2022-02-03

3.  Pre-approval and post-approval availability of evidence and clinical benefit of conditionally approved cancer drugs in Europe: A comparison with standard approved cancer drugs.

Authors:  Lourens T Bloem; Rosa E Bot; Aukje K Mantel-Teeuwisse; Menno E van der Elst; Gabe S Sonke; Olaf H Klungel; Hubert G M Leufkens; Jarno Hoekman
Journal:  Br J Clin Pharmacol       Date:  2022-01-05       Impact factor: 3.716

4.  Perspectives in the study of the political economy of COVID-19 vaccine regulation.

Authors:  Elize M da Fonseca; Holly Jarman; Elizabeth J King; Scott L Greer
Journal:  Regul Gov       Date:  2021-05-24

5.  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 in total

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