House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA
By Zachary Brennan -
Published 10 November 2017
The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected.
Categories: News, US, FDA, Drugs, In vitro diagnostics, Medical Devices
Tags: Department of Defense, emergency use authorization
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