SILVER SPRING, Md., Feb. 26, 2021 /PRNewswire/ -- Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 Vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement
- COVID-19 Vaccines
- Emergency Use Authorization for Vaccines Explained
- Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
- Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration