November 3 Public Meeting on Transparency: Hypothetical Case Studies

Below are links to the complete hypothetical case studies discussed by participants at the public meeting on November 3.

• Emerging Safety Issues Concerning FDA-Regulated Products
  • Hypothetical Case Study 1.1
  • Hypothetical Case Study 1.2
• Product Applications That Are Abandoned or Withdrawn by the Applicant Before Approval
• Agency Decisions About Pending Product Applications