www.fdanews.com/articles/114646-pdufa-five-year-drug-safety-plan-is-finalized
PDUFA Five-Year Drug Safety Plan Is Finalized
February 16, 2009
The FDA is planning to develop and publish a guidance document on risk evaluation and mitigation strategies and safety labeling, according to the agency’s final five-year drug safety plan. The final plan highlights the greater role played by the Office of Surveillance and Epidemiology in the agency’s drug safety activities.
Drug Industry Daily
Drug Industry Daily