Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency
- 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 Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Veterinary Medicine (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, September 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products Drug Industry Manufacturing and Industrial Facilities COVID-19 United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- FDA plays a critical role in protecting the United States from threats such as 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. FDA is issuing this guidance to help drug and biological product manufacturers1 during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply. Except as noted in this guidance, this policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (9 pages)).
- NLM Unique ID:
- 9918232104006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918232104006676