United States Army Medical Materiel Development Activity

The United States Army Medical Materiel Development Activity (USAMMDA), a subordinate unit of the U.S. Army Medical Research and Materiel Command at Fort Detrick, Maryland, serves as the U.S. Army’s executive agent for the development of new drugs, vaccines, and medical devices for service members.

USAMMDA product managers take promising new concepts and technologies developed in U.S. Army laboratories, guide them through the regulatory bureaucracy to obtain U.S. Food and Drug Administration certification, and develop plans for fielding products in conjunction with a sister agency, the U.S. Army Medical Materiel Agency (USAMMA).

Overview

USAMMDA is the Department of Defense’s (DoD) advanced development activity for products designed to protect and preserve the lives of service members. USAMMDA develops new drugs, vaccines, and medical support equipment that enhance readiness, ensures the provision of the highest quality medical care to the DoD, and maximizes survival of medical casualties on the battlefield.

USAMMDA project managers guide the advanced development of medical products for the U.S. Army Medical Department, other U.S. Services, the Joint Staff, the Office of the Secretary of Defense and U.S. Special Forces community. The process takes promising technology from DoD and academia to U.S. Forces, from the testing required for FDA approval or licensing to fielding of the finished product.

Mission and vision

Mission: Develop and deliver quality medical solutions to protect, treat, and sustain the health of Our service members.

Vision: USAMMDA is the premier developer of world class military medical solutions.

Project Management Offices

USAMMDA project managers address critical readiness issues identified in user requirement documents to meet cost, schedule and performance objectives. Tailored procurement, rapid prototyping and a variety of cooperative and contractual arrangements with academia and industry are among the most current acquisition procedures used. Project Management Offices (PMO) include:

Regulatory Divisions

Division of Regulated Activities and Compliance (DRAC) is a multidisciplinary team of regulatory affairs and compliance professionals dedicated to support the USAMMDA mission. DRAC provides full service regulatory support for products through the DoD acquisition spectrum, from individual investigator-initiated clinical studies to products in the advanced development pipeline. DRAC carries out its delegated responsibilities as the Office of The Surgeon General Sponsor’s (OTSG) representative for the Army regarding medical materiel development, and its operations are mandated in FDA, DoD, and Army regulatory requirements. DRAC supports investigators at medical centers and laboratories, institutional review boards, and product development teams in laboratories and advanced development organizations throughout the Army and the DoD.

Clinical Service Support Division (CSSD) supports the development of medical products by providing expert assistance in the areas of IND product manufacturing, testing and accountability; clinical study monitoring; clinical data management; biostatistics, including study design and data analysis; and adverse event monitoring and reporting.

Executive Agency

Force Health Protection-Investigational New Drugs (FHP-IND) is an Executive Agency under the Army OTSG. FHP-IND provides services to all DoD Components as the lead organization for using medical products under Emergency Use Authorizations (EUA) or IND applications in response to chemical, biological, radiological, or nuclear warfare or terrorism and other health threats. FHP-IND provides an urgent treatment capability using novel investigational countermeasures to protect U.S. Forces against man-made or natural threats in accordance with federal regulations and DoD instructions.

Critical Tasks:

References

External links

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