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.