Division of Regulated Activities and Compliance Spotlight
The U.S. Army Medical Materiel Development Activity works as an advanced product development team to provide medical solutions to our nation's service members. As an advanced developer, not only does USAMMDA contribute medical product solutions, but it also has the unique responsibility to ensure U.S. Food and Drug Administration approval on medical products. The responsibility to obtain FDA approval falls on a single division within USAMMDA, the Division of Regulated Activities and Compliance, which works to support Office of The Surgeon General-sponsored medical products through the regulatory development lifecycle to obtain FDA approval. DRAC is a multidisciplinary team of regulatory affairs and compliance professionals dedicated to supporting the USAMMDA mission.
"DRAC has three primary responsibilities," said Dr. Robert Miller, director of DRAC. "First, it provides regulatory strategy to guide the products through the FDA review hurdles by the most direct and cost-effective route. Strategy development is done as part of the IPT [Integrated Product Team] process and consultation with other internal regulatory experts. The second responsibility is to prepare timely and accurate submissions and maintain the IND submissions, FDA correspondence, and trial documents in a 21 CFR part 11-compliant database system called the Sponsor's Electronic Regulatory Files. Finally, DRAC interfaces with the FDA at all levels such as formal meetings, responses to requests for information, and informal email and telephone communication."
DRAC is comprised of four branches, including three regulatory affairs branches and a regulatory submissions branch. The regulatory submissions branch is responsible for submissions to the FDA or other agencies. This branch provides medical writing and editorial support, as well as serious adverse event reporting. The regulatory submissions branch play a key role in USAMMDA's ability to acquire the FDA licensing needed for the products that are researched and studied to aid service members.
The three regulatory affairs branches are Pharmaceuticals, Vaccines and Blood Products, and Medical Devices. These branches offer support for by providing professional expertise to support the entire Command, as well as outside partners to achieve the mission.
Recent accomplishments of DRAC include:
- Leading the regulatory effort on a promising investigational device to benefit soldiers with balance disorders
- Providing regulatory affairs support to U.S. Army Institute of Surgical Research as it develops software to aid in the resuscitation of severely burned patients
- Advising and supporting effort for the development of diagnostic for traumatic brain injury
- Working with the U.S. Army Medical Research and Materiel Command and Department of Veterans Affairs to get Trazodone, a generic antidepressant, approved for the treatment of combat-related Post Traumatic Stress Disorder
- Eight pre-Emergency Use Application packages have been accepted by the FDA for diagnostic devices developed by the U.S. Army Medical Research Institute of Infectious Diseases
- Moved to an all-electronic document storage system, which will greatly reduce costs related to contracted storage fees for paper documents
"Our number one priority is developing better and safer medical products for the warfighter as quickly as possible," said Miller.
DRAC works with an extensive list of collaborating partners, including several divisions and project management offices within USAMMDA including, Clinical Services Support Division, Division of Investigational New Drugs for Force Health Protection, Pharmaceutical Systems Project Management Office, Neurotrauma and Psychological Health Project Management Office and Integrated Regenerative and Restorative Medicine Management Team. DRAC also partners with several of the USMRMC subordinate commands, such as the Walter Reed Army Institute of Research, U.S. Army Research Institute of Environmental Medicine, USAMRIID and USAISR. Along with the internal partners, DRAC collaborates with the following external organizations: Chemical-Biological Medical Systems, U.S. Special Operations Command, U.S. Central Command, U.S. Air Force, FDA Office of Counterterrorism and Emerging Threats, and VA.
Currently, "[DRAC is] developing our own electronic Common Technical Document submission system (electronic submission mandated by the FDA) in collaboration with eIT PMO to save money and to shorten the timelines for submissions," said Miller.
The divisions and project management offices within USAMMDA, such as DRAC, are working to advance the medical solutions for our service members. The professionals working in DRAC are proving successful at pursuing advancement through all circumstances to deliver what our soldiers need, when they need it. These medical achievements that DRAC is helping to obtain will benefit the future of Army Medicine.
According to Miller, the future of DRAC will be to develop regulatory strategy as early as possible in the development of a potential FDA-regulated product to ensure that it can achieve FDA approval at the lowest cost and in the least amount of time.