美国FDA 指导原则 根据FDA 1996年出口改革和加强法制定的工业出口指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry and Food and Drug Administration Staff GUIDANCE Guidance Issued on May 16, 2016 The draft of this document was issued on August 16, 2011. This document supersedes “Guidance for Industry and FDA Staff; Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act,” issued on