What We Do:
The Regulatory Affairs Branch (RAB) serves as the Sponsor’s Representative for all DTMC regulatory applications filed with the U.S. FDA. The RAB assures regulatory compliance in the preparation, submission, and maintenance of all FDA filings supporting the conduct of clinical studies, as well as those filings allowing for the distribution of drug products available through the NIDA Drug Supply Program.
The RAB oversees the Regulatory Affairs Program which offers regulatory support to academic and industry investigators developing drugs, biologics, devices, or digital therapeutics applications to treat Substance Use Disorders.
For questions or inquiries about this program please contact: Julia Solarczyk Donnelly, M.S., RAC, Chief, Regulatory Affairs Branch at (301) 451-7262, email: julia.donnelly@nih.gov.
Staff Biographies and Research Interests:
- Julia Solarczyk Donnelly, M.S., RAC - Branch Chief
301-451-7262
Manages day-to-day operations of the RAB. Responsible for providing regulatory expertise and strategy for the DTMC and regulatory consulting within NIDA. Serves as a DTMC liaison with regulatory agencies, investigators, and collaborators. Previous experience includes more than two decades as a regulatory professional in the Maryland biotechnology industry, including over eight years as a regulatory scientist with the Department of the Army. Joined DTMC in 2023. - Marta De Santis, Ph.D., - Senior Regulatory Affairs Specialist/Health Scientist Administrator
301-827-5922
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 clinical trials are performed in compliance with all applicable regulatory requirements. Leads the Regulatory Affairs Program that provides guidance to NIDA investigators and development partners on regulatory issues and consults on clinical support contracts. Previous experience includes five years working as a Toxicologist and Regulatory Affairs Specialist in the area of cancer research. Joined DTMC in 2006.