 The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about Emergency Use Authorizations, vaccines, therapies and diagnostic tests. Q: What is the FDA doing to respond to the COVID-19 pandemic? A: The FDA, along with other federal, state, and local agencies and public health officials across the country and internationally, plays a critical role in protecting public health during the COVID-19 pandemic. FDA staff are working round-the-clock to support development of medical countermeasures and are providing regulatory advice, guidance, and technical assistance to advance the development and availability of vaccines, therapies, diagnostic tests and other medical devices for use diagnosing, treating, and preventing this novel virus. The FDA continues to monitor the human and animal food supply and take swift action on fraudulent COVID-19 products. Q: What is an Emergency Use Authorization, and how is it being used to respond to COVID-19? A: In certain types of emergencies, the FDA can issue an Emergency Use Authorization, or EUA, to provide more timely access to critical medical products (including medicines and tests) that may help during the emergency when there are no adequate, approved, and available alternative options. The EUA process is different than FDA approval, clearance, or licensing because the EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria within weeks rather than months to years. EUAs are in effect until the emergency declaration ends but can be revised or revoked as we evaluate the needs during the emergency and new data on the product's safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA. Q: Are there any vaccines or other medical products available to prevent COVID-19? A: Yes. On Dec. 11, 2020, the FDA issued the first Emergency Use Authorization for a COVID-19 vaccine, and on Dec. 18, 2020, authorized a second COVID-19 vaccine.
Additionally, the FDA is working with other vaccine developers, researchers, and manufacturers to help expedite the development and availability of medical products such as additional vaccines, monoclonal antibodies, and other drugs to prevent or treat COVID-19. Read more about what the FDA is doing to mitigate the effects of COVID-19. For information about vaccine clinical trials for COVID-19 visit clinicaltrials.gov and the COVID-19 Prevention Network. Note: The information on clinicaltrials.gov is provided by the sponsor or principal investigator of a clinical trial. The listing of a study on the site does not reflect evaluation or endorsement of the trial by the Federal government. For more information about COVID-19, visit: | 
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