Manufacturing, supply chain, and drug and biological product inspections during COVID-19 public health emergency: questions and answers
- 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. United States. Food and Drug Administration. Office of Regulatory Affairs, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, May 17, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products COVID-19 Drug Industry Quality Control 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 provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products. This document updates the guidance of the same title issued in August 2020, and revised in January 2021. 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) (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 (11 pages)).
- NLM Unique ID:
- 9918350581606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918350581606676