Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin

Author:

Fain Kevin12,Alexander G. Caleb123

Affiliation:

1. Department of Epidemiology; Johns Hopkins Bloomberg School of Public Health; Baltimore MD USA

2. Center for Drug Safety and Effectiveness; Johns Hopkins University; Baltimore MD USA

3. Division of General Internal Medicine, Department of Medicine; Johns Hopkins Medicine; Baltimore MD USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference18 articles.

1. Frances Kelsey honored for FDA legacy;Kuehn;JAMA,2010

2. The Food and Drug Administration Amendments Act and postmarketing commitments;Fain;JAMA,2013

3. U.S. Food and Drug Administration Drug safety report: advances in FDA's safety programs for marketed drugs 2012 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM300946.pdf

4. U.S. Food and Drug Administration Drug safety information for healthcare professionals 2013 http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/default.htm

5. U.S. Food and Drug Administration Medication guides 2013 http://www.fda.gov/drugs/drugsafety/ucm085729.htm

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