Division Director: Mary Kremzner, PharmD, MPH
Deputy Director: Catherine Chew, PharmD
CDER Small Business and Industry Assistance (SBIA) Program Director: Brenda Stodart, PharmD
The Division of Drug Information (DDI) is CDER's focal point for public inquiries regarding human drug products. Our mission is to optimize CDER's educational and communication outreach efforts to the global community. We accomplish this by engaging in effective internal and external interactions to provide timely, accurate, and useful information through traditional and social media channels.
DDI is staffed with a team of pharmacists and other health professionals who provide expert advice and guidance regarding all aspects of the center’s activities. We work with U.S. and international consumers, health care professionals, insurance companies, pharmaceutical companies, academia, law enforcement, and other government agencies.
What is DDI’s Role?
- Respond to public inquiries about human drug products received by phone, email, social media and mail. On average, we respond to more than 4,432 telephone calls, 1,531 emails and 91 letters every month.
- Use social media to communicate the latest drug information.
- Facebook - Engaging our stakeholders in two-way conversations
- Twitter – Follow us @FDA_Drug_Info.
- Video podcasts – FDA Drug Info Rounds is a series of training videos for practicing clinical and community pharmacists.
- Audio podcasts – Drug Safety Podcasts are broadcast in conjunction with the release of new drug safety communications about emerging safety information.
- ListServ – Subscribe to receive the latest drug information by email.
Educate specific audiences through CDERLearn, a strategic initiative to inform and educate people about the safe use of medicine, the drug regulatory process and many other important issues. Continuing Education (CE) credit is available for pharmacists, physicians, and nurses.
Lead the CDER Small Business and Industry Assistance (SBIA) program. We assist small domestic and international pharmaceutical companies seeking information about the development and regulation of human drug products. We provide various outreach activities including workshops and webinars.
Respond to trade press inquiries. Our trade press team provides members of the trade press with accurate and timely information regarding CDER policies, programs, and initiatives. The team facilitates nteractions between members of the trade press and FDA subject matter experts, and also alerts FDA staff to reports about the agency in trade publications.
Administer the FDA Pharmacy Student Experiential Program and lecture series which give pharmacy students an opportunity to learn about the FDA’s multidisciplinary processes for addressing public health issues.
Lead the Regulatory Pharmaceutical Fellowship. FDA participates with industry and academia in this two-year fellowship program that exposes fellows to one of two tracks focused on the medical and regulatory aspects of drug information dissemination or drug product marketing.
Deliver student webinars on FDA initiatives and ongoing FDA activities for pharmacy students, medical students, nurse practitioner students, and interested health care professionals in the United States.
Alert the public on recall and shortage information. DDI works closely with CDER’s Office of Compliance on issues of drug availability. When a drug shortage or recall occurs, compliance officers alert our division and provide information for us to share with the public.
Provide a drug identification service. DDI staff can help identify drugs based on their physical appearance and markings. Email the drug description and imprint to firstname.lastname@example.org.
Do you have a question? Please email, call, or write to DDI. Have any medicine-related issues or concerns you would like to share? Please tell us about your experience.
DDI Phone: 855-543-3784 | 301-796-3400 | Fax: 301-431-6353 | Email: email@example.com
CDER SBIA Phone: 866-405-5367 | 301-796-6707 | Email: CDERSBIA@fda.hhs.gov
Hillandale Building 10001 New Hampshire Avenue Silver Spring, MD 20993