The Food and Drug Administration and the Defense Department have kicked off a joint program to speed up the development and availability of emergency medical products for the U.S. military.
FDA said Tuesday the program’s framework was established through a bill, which authorized DoD to request the accelerated development and evaluation of medical products meant to diagnose, treat or prevent life-threatening conditions affecting U.S. service members.
“The FDA is fully committed to working closely with our federal partners in the DoD to expedite availability of medical products essential to the health of our military service members, particularly those products used to treat injuries in battlefield settings,” said FDA Commissioner Scott Gottlieb.
FDA will work with the office of the assistant secretary of defense for health affairs to gain a better understanding of deployed personnel’s medical needs and fast-track the review of DoD’s priority medical products.
The agency will also provide technical advice to DoD’s Health Affairs office to support the rapid production of medical goods for the military, as well as identify opportunities to accelerate the availability of products that are under development.
FDA and Health Affairs will host one or more workshops this year to discuss the scientific and clinical development of products that are crucial to servicemen’s health.
Findings from the workshop will help FDA create a guidance document for commercial product developers that seek to fulfill the urgent medical needs of the U.S. military.
The program’s first phase will be carried out by Health Affairs and FDA’s Center for Biologics Evaluation and Research and will address DoD’s high-priority need for biological products such as freeze-dried plasma, cold-stored platelets and cryopreserved platelets.