Division of Drug Information (DDI)
The Division of Drug Information (DDI) is the Center for Drug Evaluation and Research’s (CDER's) focal point for public inquiries regarding human drug products. Our mission is to optimize CDER's educational and communication efforts to our global community. We accomplish this by building effective internal and external interactions to provide timely, accurate, and useful information through both traditional and social media channels. We support the Agency's mission to promote and protect public health.
DDI is staffed with a team of pharmacists and other health professionals who provide expert advice and guidance regarding all aspects of CDER activities. Our visitors include US and international consumers, health care professionals, insurance companies, regulated industry, academia, law enforcement, FDA, and other government agencies.
The Division is essentially open 365 days per year. In other words, although we take phone calls only Monday through Friday, our traditional mailbox and email account fill up daily. On average, per month, we answer approximately:
- 5,292 telephone calls
- 1,663 emails
- 180 letters
The Division serves the Center and the American people by:
- Promoting CDER Small Business and Industry Assistance (formerly Small Business Assistance) as the home of CDER’s Small Business and Industry Assistance Program. We interact with regulated industry by assisting regulated domestic and international small pharmaceutical business seeking timely and accurate information relating to development and regulation of human drug products. We provide various outreach activities including Workshops and Webinars.
- Educating specific audiences through CDERLearn, a strategic initiative to inform and educate people about the safe use of medicine, the drug regulatory process, the vital role health care professionals play to assist FDA in fulfilling its duties and many other important issues with continuing education (CE) credit for pharmacists, physicians, and nurses.
- Utilizing Social Media. DDI uses web based technology to reach audiences that prefer to receive the latest drug information in a variety of media formats.
- Twitter - delivers the latest drug information in 140 characters or less. Follow us at 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 - communicates the latest drug information by email to over 90,000 subscribers. Subscribe Here.
- Administering 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 involving drugs, biologics, and medical devices.
- Leading the Regulatory Pharmaceutical Fellowship, with industry and academia. This two year fellowship exposes selected candidates to one of two tracks focused on the medical and regulatory aspects of drug information dissemination or marketing. The program enhances a scientific link among the FDA, academia, and the pharmaceutical industry.
- Networking with drug information pharmacists through GADIS to support collaborative strategies on critical trends and transformations for addressing FDA regulatory actions.
- Responding to “Trade Press” Inquiries. Our CDER Trade Press team provides members of the trade press with accurate and timely information regarding CDER policies, programs, and initiatives. In addition to facilitating interactions between trade press and FDA subject matter experts, we also alert FDA staff to relevant FDA coverage in the trade media. We create, nurture, and maintain strong working relationships with members of the trade press.
- Providing general and ongoing assistance to ORA's Field Public Affairs Specialists (PASes) and Public Affairs Liaisons (PALs) on current issues. Our CDERPAL serves as an advocate for PASes to Center/Office management and works to ensure the involvement of PASes in Center activities.
- Delivering Student Webinars on FDA initiatives and ongoing FDA activities for healthcare professionals, pharmacy students, medical students, and nurse practitioner students in the United States.
- Providing "Questions and Answers". DDI often works internally with division scientists to create consistent overviews of important topics and emerging issues for press and the public. These take the form of "Questions and Answers" web pages. They provide more background on a new drug approval or clarification on a new or revised FDA policy.
- Alerting the Public on Recall and Shortage Information. The Division works closely with the Office of Compliance on issues of drug availability. When a drug shortage or recall occurs, the Compliance officers alert our division and provide information available to share with the public.
- Providing overviews on the Center, for visiting international regulators and local professionals. DDI pharmacists work with the Office of International Programs when foreign government officials visit the Center. We present overviews on CDER, answer questions, and provide general information.
- Providing a Drug Identification Service. Division staff identify drugs based on physical appearance and markings. Email the drug description and imprint to firstname.lastname@example.org
Do you have a question and cannot find the answer? Please email, call, or write to our Division. Have you had any medicine-related issues you would like to share? Tell us your experience.