U.S. postmarketing pharmacovigilance compliance in the midst of regulatory uncertainty.
Goldman
Stephen A
SA
Stephen A. Goldman Consulting Services, L.L.C., Morris Plains, N.J., USA.
D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D015984:Causality; D003625:Data Collection; D017277:Drug Approval / Q000458:organization & administration; D004341:Drug Evaluation / Q000379:methods; D019983:Guideline Adherence; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D017891:Pharmacoepidemiology / Q000266:history / Q000379:methods; D011358:Product Surveillance, Postmarketing / Q000379:methods; D012308:Risk Management / Q000379:methods; D017751:Safety Management / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration