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DoD, FDA partner to develop medical products for warfighters

Army Spc. Caleb Bailey, a combat medic assigned to the Joint Multinational Training Group – Ukraine moves a casualty during a mass casualty exercise. The Defense Department and Food and Drug Administration jointly launched a program, Jan. 16, 2018, to expedite developing and delivering new medical products to the warfighter. (U.S. Army photo by Sgt. Alexander Rector) Army Spc. Caleb Bailey, a combat medic assigned to the Joint Multinational Training Group – Ukraine moves a casualty during a mass casualty exercise. The Defense Department and Food and Drug Administration jointly launched a program, Jan. 16, 2018, to expedite developing and delivering new medical products to the warfighter. (U.S. Army photo by Sgt. Alexander Rector)

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WASHINGTON — The Defense Department and Food and Drug Administration launched a joint pilot program to prioritize efficiently developing safe and effective medical products to save the lives of U.S. warfighters, officials of the agencies announced yesterday in a media teleconference.

“The partnership we announced today reflects the invaluable collaboration between our organizations,” Tom McCaffery, acting assistant secretary of defense for health affairs said.

“It strengthens our ability to equip our troops with the best possible medical support, and it helps us achieve our mission of providing battlefield care to support our entire military’s effort to achieve a safer, more secure world,” he added.

The FDA is fully committed to working closely with DoD to expedite availability of medical products that are critical to the health of service members, particularly those used to treat injuries in battlefield settings, said FDA Commissioner Dr. Scott Gottlieb, a physician and medical policy expert.

“Ensuring our nation’s warfighters have safe and effective medical products is a top priority for the agency,” he said. “By standing up a collaborative program with DoD, we hope to address DoD’s immediate product priorities and ensure these products are developed and made available in the most expeditious manner possible.”

Quick Access Is Critical

Fast access to lifesaving medical products on the battlefield is part and parcel of DoD’s efforts to support forces operating around the world, McCaffery said.

“[It’s also] essential to upholding our responsibility to the men and women of our military who risk their lives for us,” he added.

FDA’s expertise and guidance will help DoD put the best, most-effective products in the hands of battlefield medical personnel, he emphasized. “We look forward to working with our FDA partners on this important pilot program to ensure delivery of critical battlefield medicine to our deployed troops around the world.”

The framework for the program was put in place through House Res. 4374, which authorized DoD to request, and the FDA to provide, assistance to expedite development, in addition to the FDA’s review of products to diagnose, treat or prevent serious or life-threatening diseases or conditions facing American military personnel, according to an FDA press release.

Working Closely on Needs

Using the law’s expanded authorities, FDA will work closely with DoD’s 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, provide ongoing technical advice to Health Affairs to rapidly develop and manufacture medical products for use by the military, and take a closer look at products under development for opportunities to push their availability, the release said.

While the availability of biological items such as blood products takes priority, the FDA and DoD are aware of the need for a broad range of medical products for service members – such as preventive vaccines and therapeutics – and these needs will continue to evolve in the future, the FDA release said.

Disclaimer: Re-published content may have been edited for length and clarity. Read original post.

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DoD Instruction 6000.16: Military Health Support for Stability Operations

Policy

This Instruction establishes policy, assigns responsibilities, and provides instructions for military health support of stability operations in accordance with the authority in Reference (a). Military health support for stability operations is hereafter referred to as medical stability operations (MSOs).

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