An open letter to the FDA regarding changes in reporting procedures for drugs and biologics proposed in the wake of the FIAU tragedy.
Johns Hopkins University, School of Hygiene and Public Health, Department of Epidemiology, Baltimore, MD 21205, USA.
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D016907:Adverse Drug Reaction Reporting Systems / Q000191:economics / Q000592:standards*; D000998:Antiviral Agents / Q000009:adverse effects; D001086:Arabinofuranosyluracil / Q000009:adverse effects / Q000031:analogs & derivatives; D000077404:Cidofovir; D003362:Cost-Benefit Analysis; D003596:Cytosine / Q000031:analogs & derivatives; D004341:Drug Evaluation / Q000191:economics / Q000592:standards*; D005568:Forms and Records Control / Q000191:economics / Q000592:standards*; D006801:Humans; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D017751:Safety Management / Q000191:economics / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
D000998:Antiviral Agents; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D001086:Arabinofuranosyluracil; C043457:fialuridine; D003596:Cytosine; D000077404:Cidofovir