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Sheraton Philadelphia University City

Oct 22, 2018 1:45 PM - Oct 25, 2018 11:00 PM

3549 Chestnut Street, Philadelphia, PA 19104

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

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Session 10: Special Regulatory Considerations for Development

Session Chair(s)

Elliott Berger, PhD, MS

Elliott Berger, PhD, MS

President

ETB Regualtory Consulting, United States

Special Protocol Assessment
Special Development Pathways

Expedited Programs for Serious Conditions
Background and Subpart E
Concepts for Expedited Programs
Expedited Programs

Fast Track
Breakthrough Therapy Designation (BTD)
Regenerative Medicine Advanced Therapy (RMAT)
Accelerated Approval
Qualified Infectious Disease Product (QIDP)
Priority Review

Orphan Products
Priority Review Vouchers

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