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August 27, 2008

Opportunities for Enhancing the FDA Guidance on Pharmacovigilance

Author Affiliations

Author Affiliations: Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington and Center for Health Studies, Group Health, Seattle (Dr Psaty); and the Department of Epidemiology, Leiden University Medical Center, Leiden, the Netherlands (Dr Vandenbroucke).

JAMA. 2008;300(8):952-954. doi:10.1001/jama.300.8.952

The Food and Drug Administration (FDA) has produced a large number of extremely useful guidances for industry. These guidances include recommendations about the development, review, and approval of various disease-specific drugs, as well as general matters related to drug metabolism/drug interactions, premarketing risk assessment, pharmacogenetics, and pharmacovigilance. In May 2008, the FDA held a public workshop to aid in the development of a draft guidance about how to use large electronic health care databases for drug safety studies.1 The draft guidance, which will be completed in fiscal year 2010 and finalized in 2011, aims ambitiously at being a major part of a national strategy to monitor medical product safety.2