Following the Pentagon’s criticism of the US Food and Drug Administration’s (FDA) sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s (DoD) Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products. The framework for the program was established, via H.R.4374 , after DoD sought to crea...

The US Food and Drug Administration (FDA) may be the federal government's regulator of most medical products, but at least one federal agency is looking to conduct basic reviews of the safety and efficacy of one type of medical product FDA says it has the authority to regulate. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process—a difficult and e...

US regulators are set to reassess the benefits and risks of hydroxyethyl starch (HES) solutions at an upcoming workshop co-sponsored by an unusual combination of federal agencies. Regulators from the US Food and Drug Administration (FDA) will join along with the Department of Defense (DOD), the National Institutes of Health (NIH)'s National Heart, Lung and Blood Institute and a wide variety of other participants from academia, industry and other stakeholders to discuss...

The United States has been working to develop countermeasures to potential biological terror attacks on U.S. soil and abroad.  In response to the anthrax attacks of 2001 and later simulations by the National Security Council and Johns Hopkins University that estimated that a coordinated smallpox attack could kill up to one million U.S. citizens, the Department of Defense started the Transformational Medical Technologies Initiative in 2006 to develop what it refers to...