FDA and Pentagon forge breakthrough designation agreement
Following the Pentagon’s criticism of the FDA sluggishness in approving a French freeze-dried plasma product, which some have said other countries’ troops have used for years, FDA and the Department of Defense’s Office of Health Affairs on Tuesday launched a joint program to prioritize the efficient development of such medical products.
The framework for the program was established, via H.R.4374, after DoD sought to create its own review pathway whereby it could approve medical products outside of FDA’s purview.
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