Pharmacoepidemiologic Studies Should Estimate AE Background Rates – FDA
Executive Summary
Pharmacoepidemiologic risk assessment by drug companies should include an estimate of background rates for the adverse event being studied, FDA said in its 1draft concept paper on pharmacovigilance
You may also be interested in...
Post-Marketing Safety Surveillance Should Include Data Mining, FDA Says
FDA proposes data mining as one technique useful for drawing connections between products and adverse events in a draft guidance on post-marketing safety surveillance
Post-Marketing Safety Surveillance Should Include Data Mining, FDA Says
FDA proposes data mining as one technique useful for drawing connections between products and adverse events in a draft guidance on post-marketing safety surveillance
PhRMA Wants Clearer Definition Of Safety “Signal”; FDA Proposes Newsletter
FDA's upcoming pharmacovigilance guidance should include a clearer definition of what constitutes a drug risk "signal," the Pharmaceutical Research & Manufacturers of America maintains