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Regulatory Affairs Branch
Mission: To support the clinical development of new medications, or new indications for marketed medications, for the treatment of drug abuse and/or nicotine dependence by ensuring that clinical studies performed are in compliance with all applicable policies, regulations and laws. The branch also supports clinical development by coordinating technology transfer activities.
The RAB provides technical and administrative leadership to DPMCDA's effort in recruiting industry and other development partners, acquiring new testing compounds, identifying barriers to medication development and proposing development strategies. The RAB serves as the MDP's primary contact to the U.S. Food and Drug Administration (FDA). In this capacity, the RAB conducts the filing of Investigational New Drug (IND) applications, and supporting documents as new medications enter or complete clinical studies and ensures that MDP's studies are in compliance with all applicable U.S. regulatory requirements. Consultation and advice on regulatory requirements, nonclinical and clinical medication development requirements and strategy is provided to NIDA grantees, potential development partners, federal agencies, contractors, and other interested parties regarding projects of mutual interest. The RAB also provides DPMCDA technology transfer activities via relationships with Offices of the General Counsel, Office of the Secretary (HHS), and the NIH Office of Technology Transfer.
Regulatory Affairs Branch Staff Contacts
Robert Walsh, R.A.C., Chief
301-443-9825
rwalsh@nih.gov
Manages and directs the overall activities of the Regulatory Affairs Branch, including Investigational New Drug (IND), New Drug Application (NDA) and Drug Master File (DMF) submissions. Responsible for ensuring that all clinical trials are performed in compliance with all applicable regulatory requirements. Provides guidance to NIDA investigators and development partners on regulatory issues and consults on clinical support contracts, importation of compounds from foreign sources, and Drug Enforcement Administration registration of contract testing facilities. Served as Project Manager for the development of LAAM. Served as Project Director for the development of buprenorphine, and as Study Director for the NIDA/VACSP study of office-based buprenorphine treatment. Serves as Project Director for the development of other potential drug abuse treatment agents. Serves as a division liaison to the Food and Drug Administration, Drug Enforcement Administration and other governmental regulatory agencies. Provides Project Management consultation to division staff and collaborators. Total of nineteen years experience in NIDA - three years in NIDA's Division of Preclinical Research prior to joining DPMCDA in 1989.
Marta DeSantis, Ph.D., Regulatory Affairs Specialist
301-443-0886
mdesantis@nida.nih.gov
Manages the development and compilation of Investigational New Drug (IND), New Drug Application (NDA) and Drug Master File (DMF) submissions. Responsible for helping to ensure that all clinical trials are performed in compliance with all applicable regulatory requirements. Provides guidance to NIDA investigators and development partners on regulatory issues and consults on clinical support contracts. Previous experience includes 5 years working as a Toxicologist and Regulatory Affairs Specialist in the area of cancer research. Joined DPMCDA in 2006.
Regulatory Affairs Branch (RAB)
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard
Room 4123, MSC 9551
Bethesda, Maryland 20892-9551
(301) 443-1428
(301) 443-2599 (fax)
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