U.S. Army Medical Materiel Development Activity (USAMMDA) logo
U.S. Army Medical Materiel Development Activity

Authorization & Regulatory Guidance

The USAMMDA FHP division facilitates Investigational New Drug (IND) and Emergency Use Authorization (EUA) product use approval by the Assistant Secretary of Defense for Health Affairs (ASD(HA)), as required by DoDI 6200.02.

Establishes and manages FDA-compliant protocols, product procurement, shipment and inventories, and regulatory reporting, and interfaces with the USAMRMC Institutional Review Board (IRB) as the IRB of record for DoDI 6200.02 protocols to enable execution of protocols worldwide, during emergent events or contingency operations.

Partners with other federal advanced developers and the Centers for Disease Control and Prevention (CDC) to identify products for portfolio inclusion.

DoD Instruction 6200.02 Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs


 


 


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Last Modified Date: 01/21/2020