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An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a ...
(The Center Square) – Facing personnel shortages and pandemic disruptions, the U.S. Food and Drug Administration has failed to meet requirements for food safety inspections since 2018, according ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
In late September, the FDA said it planned to announce additional criteria for emergency approval of a vaccine: to ensure that the vaccine is safe and effective, the clinical trial reportedly must follow trial participants for at least two months after their second shot, and the placebo group must show at least five severe cases of COVID-19 and ...
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases.
With the Delta coronavirus variant posing a serious risk to unvaccinated Americans, some experts are calling for the FDA to fully approve the Pfizer and Moderna COVID-19 vaccines, which are ...
At present, the FDA lists over forty emergency-use approved at-home COVID tests on its website from over thirty different brands. Some tests are rapid at-home antigen tests that give results in as ...
The FDA approval board accepted the manufacturer's argument that this was due to a previously unknown cardioprotective effect of naproxen, rather than a risk of Vioxx, and the drug was approved. In 2005, the results of a randomized, placebo-controlled study showed that Vioxx users suffered a higher rate of heart attacks and other cardiovascular ...