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Seaport Hotel

Aug 12, 2019 7:45 AM - Aug 15, 2019 5:00 PM

One Seaport Lane, Boston, MA 02210

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

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

Back to Agenda

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

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., 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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