CDER SBIA Update: FDA CDER Drug Approval Case Study

FDA CDER Drug Approval  Case Study

We are pleased to announce FDA CDER Drug Approval Case Study, a new learning tool for patient advocacy groups, patients, health professionals, small businesses, and pharmaceutical and clinical innovators to advance their knowledge of FDA’s drug regulatory processes.  We believe that we can help accelerate the delivery of innovative drug products to U.S. patients by improving our stakeholders’ drug regulatory insight and understanding.

The first case study, Drug Approval: Bringing a New Drug to the Market, provides information on navigating the drug regulatory process, including objectives of the drug development and approval process, the path a drug travels from nonclinical testing to market approval, and major elements and steps to conduct a clinical trial. This fictionalized case study based on real world scenario explores the regulatory pathway for drug approval. Exercises, activities and quizzes to reinforce learning are provided.

FDA plans to develop new drug case studies that address other regulations and regulatory concepts. If you have an idea for a case study topic, please contact the Professional Affairs and Stakeholders Engagement (PASE) group at cderpase@fda.hhs.gov.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

• Email: CDERSBIA@fda.hhs.gov
• Phone: 1-866-405-5367
• Phone: (301) 796-6707
• Website: http://www.fda.gov/cdersbia