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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 Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013 is a follow-up bill to both the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Act of 2006. These acts were focused on preparing the country to deal with possible Chemical, Biological, Radiological, and Nuclear (CBRN) attacks, a high ...
During his tenure with the FDA, White House communications staff were “almost never involved” in agency announcements unless it was an “extremely high-profile, once-in-a-decade kind of ...
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 ...
Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U ...
Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, hearing aids, and dental amalgams are examples of class II devices. Class III: Devices that are approved by the premarket approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a ...
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 ...
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.