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The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response [1] (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear ...
The primary portion of the bill dealing with this office is Section 102. Among other things, the bill requires the Assistant Secretary for Preparedness and Response, with respect to overseeing advanced research, development, and procurement of qualified countermeasures, security countermeasures, and qualified pandemic or epidemic products, to: [1]
Section 303 contains official definitions for security countermeasure, qualified countermeasure and qualified pandemic or epidemic product that will be added to the Federal Food, Drug and Cosmetic Act. [4] Section 304 focuses on the relationship between government entities and private companies working on medical countermeasures. The Secretary ...
On December 19, 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law No. 109-417, was signed into law by President George W. Bush.First introduced in the House by Rep. Mike Rogers (R-MI) and Rep. Anna Eshoo (D-CA), PAHPA had broad implications for the United States Department of Health and Human Services's (HHS) preparedness and response activities.
BARDA, a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR), works to support the development of medical countermeasures such as vaccines, drugs, and diagnostic tools to counteract health security threats.
Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the effects of a chemical, biological, radiological, or nuclear (CBRN) attack, or in the case of public health emergencies. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats.
The legislation would require that the Department of Health and Human Services (HHS) develop certain procedures concerning medical countermeasures. Specifically, HHS would need to coordinate stockpiling of countermeasures between the Biomedical Advanced Research and Development Authority (BARDA) and Centers for Disease Control and Prevention. [6]
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 ...