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The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.
On Jan. 16, 2018, FDA announced a joint program with the US Department of Defense’s (DoD) Office of Health Affairs to prioritize development of safe and effective medical products for US military personnel. The program was put in place through H.R. 4374, which authorizes the request and expedition of development and approval of medical products for the military. FDA and the Health Affairs office will work closely to assess the needs of military personnel and review priority DoD medical products. Technical advice will also be given by FDA to DoD regarding the development and manufacturing of medical products, as well as to determine if products currently under development could be expedited.
The initial phase of the program will be conducted by FDA’s Center for Biologics Evaluation and Research (CBER) and Health Affairs, which will meet on a regular basis. Workshops will also be held to discuss scientific and clinical development of products. Current high-priority DoD product programs include freeze-dried plasma, cold-stored platelets, and cryopreserved platelets.
“This enhanced collaboration will enable the agency to gain a better understanding of the health needs of those protecting our country while ensuring that the medical products made available to our service members are safe and effective,” said Anna Abram, the FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis, in a statement. “The initial program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s warfighters.”