Evaluation of FDA safety-related drug label changes in 2010

Author:

Lester Jean12,Neyarapally George A.2,Lipowski Earlene1,Graham Cheryl Fossum2,Hall Marni2,Dal Pan Gerald2

Affiliation:

1. University of Florida College of Pharmacy; Department of Pharmaceutical Outcomes and Policy; 1225 Center Drive, HPNP 3334 Gainesville FL 32611 USA

2. Food and Drug Administration; Center for Drug Evaluation and Research; 10903 New Hampshire Avenue Silver Spring MD 20993 USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference11 articles.

1. Role of postmarketing surveillance in contemporary medicine;Woodcock;Annu Rev Med,2011

2. MedWatch. The FDA safety information and adverse event reporting program safety information http://www.fda.gov/Safety/MedWatch/default.htm 2011

3. Document Archiving 2011

4. Bartholow M Top 200 Drugs of 2010 http://www.pharmacytimes.com/publications/issue/2011/May2011/Top-200-Drugs-of-2010 2012

5. Sources of post-market drug safety issues: an analysis of FDA drug safety communications;Ishiguro;Pharmacoepidemiol Drug Saf,2012

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