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: Marta De Santis, Ph.D., Acting Chief, Regulatory Affairs Branch at (301) 827-5922, email: firstname.lastname@example.org or Jennifer Wong, Ph.D., Health Scientist Administrator, Regulatory Affairs Branch at (301) 827-6267, email: email@example.com.
Staff Biographies and Research Interests:
- Marta DeSantis, Ph.D., - Acting Branch Chief
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 DTMC in 2006.
- Jennifer Wong, Ph.D., - Regulatory Affairs Specialist/Health Scientist Administrator
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.