FDA, Pentagon reveal plan to speed medical devices, drugs to military personnel

The FDA and the Pentagon said today that they’re launching a joint program to speed the development of medical products for military personnel. The federal safety watchdog and the Defense Dept.’s Office of Health Affairs said the program’s framework is based on a House bill passed last year that expands the FDA’s authority to approve the emergency use of unapproved medical treatments and aims to expedite the approval process. Critics claim the program could erode medical safety, putting U.S. soldiers at risk. “Utilizing this law’s expanded authorities, the FDA will work closely with Health Affairs to better understand the military’s medical needs for deployed personnel; give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to products under the breakthrough designation program; provide ongoing technical advice to Health Affairs to aid in the rapid development and manufacturing of medical products for use by the military; and, take a closer look at products currently under development to determine opportunities to expedite their availability,” the agencies said in a prepared statement. The first phase of the program will cover blood transfusion products for the battlefield, a high priority at the Pentagon, including freeze-dried plasma, cold-stored and cryopreserved platelets. The FDA’s Center for Biologics Evaluation will spearhead that phase, FDA and DoD said. T...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance defensedepartment Source Type: news