ufapg - An Overview
ufapg - An Overview
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PDUFA laws has expanded business involvement in drug application evaluation and included routes of attraction. PDUFA II (1997) codified the market’s suitable to meet Using the Secretary to both of those focus on and get a prepared arrangement within the adequacy of the design of clinical trials to assist efficacy statements, which happens to be binding apart from in cases in which a “substantial scientific challenge” occurs after the demo has started [PDUFA II, Sec 119]. Additionally, it directed the Secretary to produce or to use present scientific advisory panels (SAPs) to provide recommendations on approval decisions [PDUFA II, Sec 120].
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