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FDA对药物不良反应报告的新规定FDA对药物不良反应(ADR)的报告提出了两项新规定:第一项,针对处在临床试验阶段的药品,此规定主要是应FDA特别委员会的要求而制订的,FDA在审查礼莱公司用fialuridine(FIAU)治疗B型肝炎的试验数据时,...
FDA Adverse Drug Reaction Reporting New Regulations The FDA report on adverse drug reactions (ADR) has proposed two new rules: The first is for drugs in the clinical trial phase, which is primarily at the request of the FDA’s Special Committee Developed by the FDA in the review Lilly Company fialuridine (FIAU) treatment of hepatitis B test data, ...