(Download) "Applications for Food and Drug Administration Approval to Market New Drug - Revision of Postmarketing Reporting Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)" by The Law Library # eBook PDF Kindle ePub Free
eBook details
- Title: Applications for Food and Drug Administration Approval to Market New Drug - Revision of Postmarketing Reporting Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- Author : The Law Library
- Release Date : January 06, 2018
- Genre: Law,Books,Professional & Technical,
- Pages : * pages
- Size : 145 KB
Description
The Law Library presents the complete text of the Applications for Food and Drug Administration Approval to Market New Drug - Revision of Postmarketing Reporting Requirements (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 issuing an interim final rule amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act. The provisions of the Federal Food, Drug and Cosmetic Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. This interim final rule modifies the term “discontinuance” and clarifies the term “sole manufacturer” with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages.
This ebook contains:
- The complete text of the Applications for Food and Drug Administration Approval to Market New Drug - Revision of Postmarketing Reporting Requirements (US Food and Drug Administration Regulation) (FDA) (2018 Edition)
- A dynamic table of content linking to each section
- A table of contents in introduction presenting a general overview of the structure
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