About FDA

Division of Drug Information (DDI)

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 3,731 telephone calls, 1,474 emails and 64 letters every month.
  • Use social media to communicate the latest drug information.
  • 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.

  • Manages the Drug Safety Labeling Changes (SLC) database, which provides data to the public in downloadable and searchable formats. These enhancements allow health information technology vendors to more efficiently gather, organize and distribute information related to drug safety label changes.

  • 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 and healthcare professional 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 druginfo@fda.hhs.gov.

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Contact DDI

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: druginfo@fda.hhs.gov
  • CDER SBIA Phone: 866-405-5367 | 301-796-6707 | Email: CDERSBIA@fda.hhs.gov
  • Hillandale Building 10001 New Hampshire Avenue Silver Spring, MD 20993

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Page Last Updated: 05/04/2017
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