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Drug Approval Case Studies

Drug Approval Case Studies

Fact Sheet (PDF - 242 KB)

FDA Case StudyFDA is introducing a new learning tool for patients and patient advocacy groups, health professionals, small business, and pharmaceutical and clinical innovators designed to advance knowledge of drug regulatory processes. Each case study promotes active learning through exercises, instructor-led discussions, and quizzes.

The first case study, Drug Approval: Bringing a New Drug to the Market, is a detailed and engaging learning experience on how to navigate the drug approval process from conducting nonclinical testing and clinical trials to submitting a new drug application to FDA.

We plan to develop new drug case studies that address other regulatory activities. 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.  

Case Study 1. Drug Approval: Bringing a New Drug to the Market (PDF - 637 KB)