Author: The Law The Law LibraryPublisher: Createspace Independent Publishing Platform
ISBN: 9781727540314
Category :
Languages : en
Pages : 58
Book Description
Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products-including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application-to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States. This book contains: - The complete text of the Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section