ビジネス · 2019/10/171 分で読めます
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Guidance for Industry; Availability
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products." This guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This guidance finalizes the draft guidance for industry of the same title issued in June 2018.