An open letter to the FDA regarding changes in reporting procedures for drugs and biologics proposed in the wake of the FIAU tragedy.
Meinert
C L
CL
Johns Hopkins University, School of Hygiene and Public Health, Department of Epidemiology, Baltimore, MD 21205, USA.
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