Search Results for DoD

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FDA and Pentagon Forge Breakthrough Designation Agreement By Zachary Brennan - Published 16 January 2018

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.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Human cell and tissue, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Pentagon, DoD, breakthrough, freeze-dried plasma, platelets

DOD Steps Onto FDA Turf, Seeking to Evaluate Safety and Effectiveness of LDTs By Alexander Gaffney, RAC - Published 18 June 2014

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.

Categories: News, US, CDRH, In vitro diagnostics, Medical Devices, Orphan products

Tags: DOD, Department of Defense, LDTs, Lab-Developed Tests, Defense Health Agency, DHA, Demonstration Project

US Regulators, Defense Officials to Converge for Meeting on Blood Product By Alexander Gaffney - Published 24 July 2012

Categories: FDA, CBER, Blood

Tags: DOD, Meeting, Latest News, workshop

US Bioterrorism Countermeasures Run in to Regulatory, Ethical Hurdles By Alexander Gaffney - Published 03 January 2012

Categories: FDA, Ethics

Tags: Animal Rule, Countermeasures, Bioterrorism, Pentagon, DOD, Latest News, clinical trials