Search results
Results from the WOW.Com Content Network
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 ...
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]
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 ...
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 ...
The statute authorizes the FDA to award a priority review voucher to the sponsor (manufacturer) of a newly approved drug or biologic that targets a neglected tropical disease or a rare pediatric disease. The provision applies to New Drug Applications (NDAs), Biological License Applications (BLAs) and 505(b)(2) applications. The voucher, which ...
Diabetes treatment Mounjaro has been on the health regulator's shortage list since late 2022, while weight-loss drug Zepbound was added in April as demand far outstripped supply. The limited ...