What We Do:
The Regulatory Affairs Program offers regulatory expertise and support to academic and industry investigators interested in/or developing compounds, devices, or digital therapeutics applications to treat Substance Use Disorders. The goal is to assist investigators to advance therapeutic interventions through the U.S. FDA regulatory pathway. This includes but it is not limited to assisting with filing and maintenance of Investigational New Drug (IND) applications, Drug Master Files (DMFs), New Drug Applications (NDAs), and Investigational Drug Exemptions (IDEs). The ultimate goal of this program is to provide all the required technical assistance to investigators to file and/or obtain approval of New Drug Applications (NDAs) or other types of market approvals for therapeutics, devices, or digital therapeutics applications.
For questions or inquiries about this program please contact: Julia Solarczyk Donnelly, M.S., RAC, Chief, Regulatory Affairs Branch at (301) 451-7262, email: mailto:julia.donnelly@nih.gov or Jennifer Wong, Ph.D., Health Scientist Administrator, Regulatory Affairs Branch at (301) 827-6267, email: jennifer.wong3@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 DeSantis, Ph.D., - Senior Regulatory Affairs Specialist/Health Scientist Administrator
301-827-5922
Dr. De Santis manages the development and compilation of Investigational New Drug (IND), New Drug Application (NDA) and Drug Master File (DMF) submissions. Dr. De Santis received an MS and Ph.D. in Biochemistry in Argentina, and received postdoctoral training at NCI/NIH. Since joining DTMC in 2006, she has been responsible for helping to ensure that clinical trials are performed in compliance with all applicable regulatory requirements. Dr. De Santis leads a Division’s program that provides guidance to NIDA investigators and development partners on regulatory issues and consults on clinical support contracts. Her previous experience includes five years working as a Toxicologist and Regulatory Affairs Specialist in the area of cancer research. - 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.