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. - Guifang Lao, M.D., Ph.D., Health Scientist Administrator/Program Officer
301-827-5931
Dr. Lao is responsible for developing innovative research programs of HIV clinical research, justice system and training clinical research. Dr. Lao received an MD and MS in Biochemistry from China, a Ph.D. in Microbiology/Biochemistry from Cornell University, and postdoctoral training at NINDS/NIH. She also worked in biotech and pharmaceutical companies and in the Department of Radiology at the NIH Clinical Center. Over the past 25+ years, her research interests have been in the areas of clinical medicine, clinical molecular biology, immunology, neuroscience, protein chemistry, and non-invasive techniques of assessing medical consequences. She has several publications in Neuron, Neuroscience, Molecular and Cell Biology, Biochemistry, and Medicine. - Jennifer Wong, Ph.D., - Regulatory Affairs Specialist/Health Scientist Administrator
301-827-6267
Ensures that clinical trials are performed in compliance with applicable regulatory requirements. Provides guidance to NIDA investigators and development partners on regulatory issues and consults on clinical support contracts. Serves as project officer for the National Institute on Drug Abuse / Veterans Affairs Interagency Agreement. Previous experience includes six years of experience as a Regulatory Affairs Specialist and ten years of experience in clinical trials. Joined DTMC in 2020.