美国食品药品监督管理局批准新药上市的申请；修订上市后报告要求。最终规则。

Applications for Food and Drug Administration application approval to market a new drug; revision of postmarketing reporting requirements. Final rule.

出版信息

Fed Regist. 2007 Oct 18;72(201):58993-9000.

DOI:

Abstract

The Food and Drug Administration (FDA) is amending its regulations describing postmarketing reporting requirements to implement certain provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The changes apply to drug products that are life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition and that were not originally derived from human tissue and replaced by a recombinant product. The final rule implements provisions of the Modernization Act by requiring an applicant who is the sole manufacturer of one of these products to notify FDA at least 6 months before discontinuing manufacture of the drug product.

摘要

美国食品药品监督管理局（FDA）正在修订其关于上市后报告要求的法规，以实施1997年《食品药品监督管理局现代化法案》（《现代化法案》）的某些条款。这些变更适用于支持生命、维持生命或用于预防严重疾病或病症且并非最初源自人体组织且已被重组产品替代的药品。最终规则通过要求作为这些产品之一的唯一制造商的申请人在停止生产该药品前至少6个月通知FDA来实施《现代化法案》的条款。