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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) The Law Library

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) 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 book 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 table of contents with the page number of each section