CDER Division of Drug Information
Who We Are
The Division of Drug Information (DDI) serves as CDER's central resource for drug information and regulatory support. DDI pharmacists provide timely, accurate, scientific and regulatory expertise to the public, healthcare professionals, and industry through tens of thousands of responses to direct inquiries each year.
DDI’s services span the full range of CDER’s mission, including regulatory education and outreach, facilitation of emergency and single-patient expanded access requests, contributing content to drug information and safety-related labeling databases, and professional training and development activities for pharmacists and pharmacy students.
Patients, caregivers, healthcare professionals, industry professionals, and more can engage with DDI for specialized drug information expertise.
What We Do
- Interact with the public on all aspects of the Center’s activities -- engagement may be in the form of phone, email, and mail.
- Lead the CDER Small Business and Industry Assistance (SBIA) program by providing information about the development and regulation of human drug products to domestic and international pharmaceutical companies. Also, on LinkedIn
- Lead the Network of Experts (NoE) program within CDER in partnership with the Office of Translational Sciences.
- Support the Office of New Drugs in facilitating emergency and non-emergency single patient investigational new drug (IND) applications, and maintain FDA's Expanded Access webpages across CDER, CBER, and CDRH.
- Update and manage the Drug Safety-related Labeling Changes (SrLC) database, providing safety data to the public in downloadable and searchable formats; REMS@FDA database of currently approved individual and shared system Risk Evaluation and Mitigation Strategies (REMS), providing REMS information and data to the public in downloadable and searchable formats; and PEPFAR database providing information about tentatively approved and approved antiretroviral drugs.
- Administer the FDA Pharmacy Student Experiential Program, offering Advanced Pharmacy Practice Experience rotations to student pharmacists.
- Lead the Regulatory Pharmaceutical Fellowship Program, a two-year program for PharmDs offering specialized experiences in partnership with academia.
- Communicate updates and safety information via email updates for Drug Information, Small Business and Industry Assistance, Drug Safety Communications, Drug Safety-related Labeling Changes, and REMS@FDA Monthly Updates: subscribe here for email updates.
Contact Us
- Email: druginfo@fda.hhs.gov | Telephone: 855-543-3784
- Email SBIA: CDERSBIA@fda.hhs.gov | Phone: 866-405-5367
- 10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993
Past Programs:
- Four podcast series: Q&A with FDA, Drug Safety podcasts, CDER SBIA Chronicles podcasts, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
- FDA Drug Info Rounds
- FDA Drug Topics
- CDERLearn