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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 ...
Project BioShield Act of 2004; Long title: An Act To amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements, and expediting the scientific peer review process ...
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]
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]
The Public Readiness and Emergency Preparedness Act (PREPA), passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005 (as part of Pub. L. 109–148 (text)), is a controversial tort liability shield intended to protect pharmaceutical manufacturers from financial risk in the event of a declared public health emergency.
The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. [1]