Source: US Food and Drug Administration
- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
- Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on the FDA’s response efforts.
- Also today, the FDA issued a temporary guidance entitled “Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency.” This guidance explains how the agency will determine review timelines following issuance of a complete response letter when a facility assessment is necessary for FDA’s regulatory decision on an original or supplement application. The guidance applies to inspections of manufacturing facilities and also bioresearch monitoring (BIMO) program sites conducting clinical, analytical, and nonclinical studies.
- Testing updates:
- As of Dec. 21, 306 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs), including 233 molecular tests and sample collection devices, 62 antibody tests, and 11 antigen tests.
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.