Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities 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, April 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Consumer Product Safety Drug Industry Pharmaceutical Research 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 describe how we will request and conduct voluntary remote interactive evaluations at facilities2 where drugs3 are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency. 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 (13 unnumbered pages))
- NLM Unique ID:
- 9918332784306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918332784306676