FDA & DOD Developing Safe Medicines

FDA https://www.fda.gov and the Department of Defense’s (DOD) Office of Health Affairs  https://health.mil have launched a joint program to efficiently develop safe and effective medical products in order to provide better emergency care for military personnel especially when treating injuries in battlefield settings.

FDA will work closely with the DOD’s Office of Health Affairs to better understand the military’s medical needs for deployed personnel, expedite the review for DOD’s priority medical products, and in addition, FDA will provide ongoing technical advice to DOD’s Office of Health Affairs.

The framework for the program was put in place when the bill H.R.4374 introduced by Representative Greg Walden (R-OR) was enacted in December 2017. The legislation authorizes DOD to work together with FDA to develop products that are needed to diagnose, treat, or to help prevent serious or life threatening diseases affecting the military.

Since current high priority DOD product programs include freeze dried plasma, cold stored platelets, and cryopreserved platelets, the initial phase of the program will be conducted both with FDA’s Center for Biologics Evaluation and Research (CBER) and with the DOD Office of Health Affairs. Leadership from FDA’s CBER will meet with DOD’s Office of Health Affairs on a regular basis.

As part of the program, FDA and DOD’s Office of Health Affairs will hold one or more workshops in 2018 to discuss several aspects involving the scientific and clinical development of products that are important to the health of the military.

Findings from this workshop will provide information for a document to be issued to help commercial product developers identify opportunities to fulfill unmet medical needs for battlefield settings and other front-line conditions.

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