Notifying FDA of a permanent discontinuance or interruption in manufacturing under section 506C of the FD&C Act
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Pharmaceutical Preparations -- supply & distribution United States United States. Department of Health and Human Services. United States. Food and Drug Administration. United States.
- Genre(s):
- Technical Report
- Abstract:
- The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the 16 United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the United States. FDA is issuing this guidance to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain drugs and biological products that will, in turn, help the Agency in its efforts to prevent or mitigate shortages of such products. The guidance discusses the requirement under section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356c) and FDA's implementing regulations for applicants and manufacturers to notify FDA of a permanent discontinuance in the manufacture of certain products or an interruption in the manufacture of certain products that is likely to lead to a meaningful disruption in supply of that product in the United States. This guidance also recommends that applicants and manufacturers provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate shortages. In addition, the guidance explains how FDA communicates information about 36 products in shortage to the public.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (12 pages)).
- NLM Unique ID:
- 101772687 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101772687