RT Journal
A1 Psaty BM, Vandenbroucke JP
T1 OPportunities for enhancing the fda guidance on pharmacovigilance
JF JAMA
JO JAMA
YR 2008
FD August 27
VO 300
IS 8
SP 952
OP 954
DO 10.1001/jama.300.8.952
UL http://dx.doi.org/10.1001/jama.300.8.952
AB 
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 In May 2008, the FDA held a public workshop to aid in the development of a draft guidance about how to use large electronic health care databases for drug safety studies.1 The draft guidance, which will be completed in fiscal year 2010 and finalized in 2011, aims ambitiously at being a major part of a national strategy to monitor medical product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