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FDA to speed review of medical products for use by military

FDA to speed review of medical products for use by military

The U.S. Food and Drug Administration (FDA) and Department of Defense launched a program on Tuesday to speed the development and review of medical products needed by the military, such as freeze-dried plasma that could prevent wounded troops from bleeding to death.

The move follows a dispute between the FDA and the defense department over a provision in the annual defense authorization bill that would have allowed the Pentagon to authorize the emergency use of drugs and medical devices that have not been approved by the FDA.

The U.S. Senate and House of Representatives ultimately passed a bill leaving the authority to approve new medical products with the FDA, but which authorizes the defense department to request that the FDA bumps up certain products to the top of its review list.

The defense department’s top priorities include freeze-dried plasma, cold-stored platelets, and cryopreserved platelets. Platelets are blood components that help the clotting process and stop bleeding.

The FDA said it expects to have a licensed product available by the end of the year.

The agency said it plans to review priority defense department products in a way that is similar to its current breakthrough designation program, which aims to speed products onto the market by relaxing certain clinical trial requirements and offering developers intensive FDA guidance.

(Reporting by Toni Clarke in Washington; Editing by Bernadette Baum)

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