Literature DB >> 23839755

The Food and Drug Administration Amendments Act and postmarketing commitments.

Kevin Fain1, Matthew Daubresse, G Caleb Alexander.   

Abstract

Mesh：

Year:  2013        PMID： 23839755     DOI： 10.1001/jama.2013.7900

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   56.272


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  18 in total

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

Authors:  Cassandra Willyard
Journal:  Nat Med       Date:  2014-11       Impact factor: 53.440

2.  Medicines Save, Medicines Kill.

Authors:  Joel Lexchin
Journal:  Drug Saf       Date:  2017-06       Impact factor: 5.606

Review 3.  Two decades of off-label prescribing in children: a literature review.

Authors:  Shamala Balan; Mohamed Azmi Ahmad Hassali; Vivienne S L Mak
Journal:  World J Pediatr       Date:  2018-09-14       Impact factor: 2.764

4.  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

Review 5.  FDA Policy and Cardiovascular Medicine.

Authors:  Joseph S Ross; Aaron S Kesselheim
Journal:  Circulation       Date:  2015-09-22       Impact factor: 29.690

6.  Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.

Authors:  Beatrice L Brown; Mayookha Mitra-Majumdar; Jonathan J Darrow; Osman Moneer; Catherine Pham; Jerry Avorn; Aaron S Kesselheim
Journal:  JAMA Intern Med       Date:  2022-10-03       Impact factor: 44.409

7.  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

8.  Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.

Authors:  Huseyin Naci; Katelyn R Smalley; Aaron S Kesselheim
Journal:  JAMA       Date:  2017-08-15       Impact factor: 56.272

9.  US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018.

Authors:  Joshua J Skydel; Audrey D Zhang; Sanket S Dhruva; Joseph S Ross; Joshua D Wallach
Journal:  Clin Trials       Date:  2021-04-16       Impact factor: 2.486

10.  Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.

Authors:  Jenny Hwang; Thomas J Hwang; Joseph B Ciolino
Journal:  BMJ Open       Date:  2015-06-04       Impact factor: 2.692
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