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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.
The FDA may remove the REMS requirement if it is found to not improve patient safety. [ 3 ] The REMS program developed out of previous systems dating back to the 1980s for monitoring the use of a small number of high-risk drugs such as the Accutane , which causes serious birth defects, Clozaril , which can cause agranulocytosis , and ...
Ball-and-stick model of Ivermectin. Ivermectin is an antiparasitic drug that is well established for use in animals and people. [1] The World Health Organization (WHO), [2] the European Medicines Agency (EMA), [3] the United States Food and Drug Administration (FDA), [4] and the Infectious Diseases Society of America (IDSA) [5] all advise against using ivermectin in an attempt to treat or ...
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 ...
Under the plan, the Department of Health and Human Services will be authorized to invest in “domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have ...
Cenobamate was approved for medical use in the United States in November 2019, [3] [7] [8] [9] and placed in Schedule V of the Controlled Substances Act in March 2020. [10] Cenobamate was approved for medical use in the European Union in March 2021, [5] approved for use in the UK in December 2021, [11] and approved for use in Canada in June ...
The sixteenth FDA-approved antiretroviral. It was the first protease inhibitor approved for twice-a-day dosing instead of needing to be taken every eight hours. The convenient dosing came at a price, as the dose required is 1,200 mg, delivered in 8 very large gel capsules.
The National Institutes of Health (NIH) COVID-19 Treatment Guidelines states "there is insufficient evidence to recommend either for or against the use of zinc for the treatment of COVID-19" and that "the Panel recommends against using zinc supplementation above the recommended dietary allowance for the prevention of COVID-19, except in a ...