The FDA and Department of Defense's Office of Health Affairs on Tuesday unveiled a joint program to expedite the development and regulatory review of medical products for American military personnel.
Here are three things to know.
1. Through the initiative, which stems from a law enacted in December, the FDA will:
- Work with the Office of Health Affairs to better understand the medical needs of deployed military personnel
- Prioritize and expedite review of priority DOD medical products in a manner similar to the agency's breakthrough designation program
- Share ongoing technical advice with Health Affairs to aid in the rapid development and manufacturing of medical products for the military
- Examine current products under development to identify opportunities to expedite their availability
2. The agencies will first prioritize the availability of biological products such as freeze-dried plasma, cold-stored platelets and cryopreserved platelets. The FDA's Center for Biologics Evaluation and Research will work with the Office of Health Affairs to complete this task.
3. The FDA and the Office of Health Affairs will also hold at least one workshop to discuss potential changes to the scientific and clinical development of future medical products to better meet military personnel's medical needs.