Literature DB >> 33908278

Few new drugs deserve expedited regulatory treatment.

Jonathan J Darrow1.   

Abstract

DISCLOSURES: This commentary is based on work by the author that was supported by Arnold Ventures and the Harvard-MIT Center for Regulatory Science. The funders had no role in the writing of this commentary, or the decision to submit for publication. The author has nothing else to disclose.

Year:  2021        PMID： 33908278     DOI： 10.18553/jmcp.2021.27.5.685

Source DB:  PubMed          Journal:  J Manag Care Spec Pharm


  4 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

2.  Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020.

Authors:  Mayookha Mitra-Majumdar; Simon J Gunter; Aaron S Kesselheim; Beatrice L Brown; Krysten W Joyce; Murray Ross; Catherine Pham; Jerry Avorn; Jonathan J Darrow
Journal:  JAMA Netw Open       Date:  2022-05-02

3.  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

4.  Overall Survival Benefits of Cancer Drugs Approved in China From 2005 to 2020.

Authors:  Yichen Zhang; Huseyin Naci; Anita K Wagner; Ziyue Xu; Yu Yang; Jun Zhu; Jiafu Ji; Luwen Shi; Xiaodong Guan
Journal:  JAMA Netw Open       Date:  2022-08-01
  4 in total

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