Literature DB >> 25375913

FDA's post-approval studies continue to suffer delays and setbacks.

Cassandra Willyard.   

Abstract

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Year:  2014        PMID： 25375913     DOI： 10.1038/nm1114-1224

Source DB:  PubMed          Journal:  Nat Med        ISSN： 1078-8956            Impact factor:   53.440


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  2 in total

1.  The Food and Drug Administration Amendments Act and postmarketing commitments.

Authors:  Kevin Fain; Matthew Daubresse; G Caleb Alexander
Journal:  JAMA       Date:  2013-07-10       Impact factor: 56.272

2.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.

Authors:  Nicholas S Downing; Jenerius A Aminawung; Nilay D Shah; Harlan M Krumholz; Joseph S Ross
Journal:  JAMA       Date:  2014 Jan 22-29       Impact factor: 56.272
  2 in total
  2 in total

1.  Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.

Authors:  Jarno Hoekman; Thea T Klamer; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Marie L De Bruin
Journal:  Br J Clin Pharmacol       Date:  2016-04-22       Impact factor: 4.335

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
  2 in total

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