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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.
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 ...
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 ...
Ivermectin is an antiparasitic drug. [7] After its discovery in 1975, [8] its first uses were in veterinary medicine to prevent and treat heartworm and acariasis. [9] Approved for human use in 1987, [10] it is used to treat infestations including head lice, scabies, river blindness (onchocerciasis), strongyloidiasis, trichuriasis, ascariasis and lymphatic filariasis.
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 ...
The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi). It helps support "partner" agencies and organizations prepare for public health emergencies that could require MCMs. Its partners include government agencies at all levels of government, NGOs, universities, research centers, and FDA medical product centers. [13]
See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page. This is a dynamic list and may never be able to satisfy particular standards for completeness. You can help by adding missing items with reliable sources .
It includes laboratory research on microorganisms and animals, filing for regulatory status, such as via the FDA, for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.