Literature DB >> 29211663

Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.

Jonathan J Darrow1, Jerry Avorn1, Aaron S Kesselheim1.   

Abstract

Mesh:

Year:  2017        PMID: 29211663     DOI: 10.1056/NEJMhle1710706

Source DB:  PubMed          Journal:  N Engl J Med        ISSN: 0028-4793            Impact factor:   91.245


× No keyword cloud information.
  4 in total

1.  The Prescription Drug User Fee Act: Much More Than User Fees.

Authors:  Aaron P Mitchell; Niti U Trivedi; Peter B Bach
Journal:  Med Care       Date:  2022-04-01       Impact factor: 2.983

Review 2.  Can we learn lessons from the FDA's approval of aducanumab?

Authors:  Kathy Y Liu; Robert Howard
Journal:  Nat Rev Neurol       Date:  2021-09-17       Impact factor: 42.937

3.  The Potential Benefit of Expedited Development and Approval Programs in Precision Medicine.

Authors:  Ariel Kantor; Susanne B Haga
Journal:  J Pers Med       Date:  2021-01-14

4.  Commentary: Expedited Regulatory Review of Low-Value Drugs.

Authors:  Jonathan J Darrow; Reed F Beall
Journal:  Healthc Policy       Date:  2020-05
  4 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.