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Bethesda North Marriott Hotel and Conference Center

Apr 08, 2019 1:45 PM - Apr 11, 2019 11:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Affairs: The IND, NDA, and Post-Marketing

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Session 10: Special Regulatory Considerations for Development (includes a 15 minute refreshment break)

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

  • Expedited Programs for Serious Conditions
    • Background and Subpart E
    • Concepts for Expedited Programs
      • Serious Conditions
      • Available Therapy
      • Unmet Medical Need
    • Expedited Programs
      • Fast Track
      • Breakthrough Therapy Designation (BTD)
      • Regenerative Medicine Advanced Therapy (RMAT)
      • Accelerated Approval
      • Qualified Infectious Disease Product (QIDP)
      • Priority Review
    • Other Programs
      • The Animal Rule
      • Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD)
      • Orphan Products
      • Priority Review Vouchers
    • Overview of Special Development Programs

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