COVID-19: potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity
- 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.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Antibodies, Monoclonal COVID-19 -- drug therapy Enzyme-Linked Immunosorbent Assay SARS-CoV-2 Viral Plaque Assay United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
- 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:
- 9918250311706676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918250311706676