Literature DB >> 18046024

Bolstering the FDA's drug-safety authority.

William B Schultz1.   

Abstract

Mesh:

Year:  2007        PMID: 18046024     DOI: 10.1056/NEJMp078212

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


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  12 in total

Review 1.  Assessing long-term drug safety: lessons (re) learned from raptiva.

Authors:  Nicole M Seminara; Joel M Gelfand
Journal:  Semin Cutan Med Surg       Date:  2010-03

Review 2.  Strategies for postmarketing surveillance of drugs and devices in patients with ESRD undergoing dialysis.

Authors:  Moshe Vardi; Robert W Yeh; Charles A Herzog; Wolfgang C Winkelmayer; Soko Setoguchi; David M Charytan
Journal:  Clin J Am Soc Nephrol       Date:  2013-08-22       Impact factor: 8.237

3.  Increasing transparency at the FDA: the impact of the FDA Amendments Act of 2007.

Authors:  Susan F Wood; Kristen L Perosino
Journal:  Public Health Rep       Date:  2008 Jul-Aug       Impact factor: 2.792

4.  Post-marketing assessment of the safety of strontium ranelate; a novel case-only approach to the early detection of adverse drug reactions.

Authors:  Anthony Grosso; Ian Douglas; Aroon Hingorani; Raymond MacAllister; Liam Smeeth
Journal:  Br J Clin Pharmacol       Date:  2008-07-31       Impact factor: 4.335

5.  Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

Authors:  Daniel M Cook; Rama K Gurugubelli; Lisa A Bero
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

6.  Off-label use of rituximab in a multipayer insurance system.

Authors:  Eliezer M Van Allen; Todd Miyake; Nathan Gunn; Caroline M Behler; Jeff Kohlwes
Journal:  J Oncol Pract       Date:  2011-03       Impact factor: 3.840

Review 7.  Regulating prescription drugs for patient safety: does Bill C-17 go far enough?

Authors:  Matthew Herder; Elaine Gibson; Janice Graham; Joel Lexchin; Barbara Mintzes
Journal:  CMAJ       Date:  2014-03-10       Impact factor: 8.262

8.  Quantitative risk-benefit analysis of natalizumab.

Authors:  J P Thompson; K Noyes; E R Dorsey; S R Schwid; R G Holloway
Journal:  Neurology       Date:  2008-07-29       Impact factor: 9.910

9.  Off-label prescribing: a call for heightened professional and government oversight.

Authors:  Rebecca Dresser; Joel Frader
Journal:  J Law Med Ethics       Date:  2009       Impact factor: 1.718

10.  The Weber effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010.

Authors:  Keith B Hoffman; Mo Dimbil; Colin B Erdman; Nicholas P Tatonetti; Brian M Overstreet
Journal:  Drug Saf       Date:  2014-04       Impact factor: 5.606

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