FDA, DoD formalize medical product development deal

The FDA said last Friday that it and the U.S. Department of Defense’s Office of Health Affairs inked a Memorandum of Understanding to support medical product development  intended to support military personnel.

The deal creates a framework through which the FDA and DOD can implement “enhanced engagements” that were part of a law passed by Congress last year.

“We’re extremely grateful to the men and women who defend our nation, often at great personal risk and sacrifice. It’s our honor and duty to support our military personnel by ensuring they have access to safe and effective medical products – especially products that meet the unique needs and settings in which soldiers may require medical treatment. The FDA has already been working closely with the DoD to identify opportunities to expedite availability of medical products, particularly those products used to treat injuries in battlefield settings. For example, as noted below, the Emergency Use Authorization for French freeze-dried plasma that was issued earlier this year. Our close collaboration with DoD has helped us target and more efficiently address DoD’s immediate product priorities and foster development and review of these products in the most streamlined manner possible. We are looking forward to additional partnership opportunities under the MOU,” FDA Commissioner Dr. Scott Gottlieb said in a press release.

The FDA will work closely with the DoD to explore how to support and promote access to safe and effective medical products to serve the military’s medical needs. The agreement also includes expedited review and attention for DoD medical products and technical advice and support of the rapid development of such products for use in the military.

The partnership builds upon an approach the FDA outlined this year looking to advance the development and availability of products intended to save the lives of American military personnel, and “reflects the agency’s commitment to working to address the medical needs of military personnel,” according to the FDA notice.

“This MOU furthers the existing partnership between the Department of Defense and the FDA to equip our military with the best and most innovative military medical support possible. Our servicemen and women risk their lives protecting our country. Today’s MOU reflects the commitment of the DoD and the FDA to ensure timely access to life-saving medical products for U.S. troops and to continue fostering the development of new innovative medical products that can help ensure the operational readiness of American troops. We look forward to continuing to work with the FDA as we analyze and implement measures to provide the best possible medical products and care to all military personnel – on the battlefield, stationed around the world and at home,” U.S. DoD Health Readiness Policy & Oversight Acting division Deputy Assistant Secretary of Defense Terry Rauch said in a prepared statement.

In July, the FDA said that it granted an emergency use authorization to the US Department of Defense for the use of particular freeze-dried plasma products designed for the treatment of hemorrhage or coagulopathy.

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