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The law grants the FDA transformative, new authorities that will meaningfully advance our efforts to modernize the OTC drug development and review process to help advance innovative, safe and ...
25 maj 2023 · PAXLOVID is the first FDA-approved oral treatment for COVID-19; has been authorized for emergency use since December 2021. Approval is based on the totality of scientific evidence submitted, including efficacy data from the Phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalization or death from any cause in ...
By Jonathan Iwry. The ongoing fight against COVID-19 has brought widespread public attention to FDA and its power to grant emergency use authorizations (EUAs), which permits FDA to authorize formally unapproved medical products for emergency use against threats to public health and safety.
This legislation established the EUA under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which permitted the emergency use of unapproved countermeasures against chemical, biological, radiological, or nuclear (CBRN) agent(s), among other authorities, when there are no adequate, approved, and available alternatives .
28 sty 2021 · The act called for billions of dollars in appropriations for purchasing vaccines in preparation for a bioterror attack, and for stockpiling of emergency countermeasures. To be able to act rapidly in an emergency, Congress allowed FDA to authorize formally unapproved products for emergency use against a threat to public health and safety ...
11 kwi 2023 · President Roosevelt signs the Emergency Banking Relief Act into law. The law aims to shore up the nation’s troubled banking – for example, by examining the financial health of individual banks. March 12, 1933:
24 sty 2018 · PEPFAR was created by President George W. Bush, who felt strongly that as a resource-rich and privileged country, the United States was morally obligated to help people in low-income countries...
