Agenda Details

Learn more about sessions and presentations at the 25th Annual Meeting

Detailed Program

Accelerated Approval for Gene Therapies (Organized by the Government Relations Committee)

FDA's accelerated approval pathway has received significant attention in recent months. This symposium is intended to discuss the accelerated approval pathway and its unique relevance to gene therapy development. The program will address the significance of the program in treating rare diseases, current developments in policy surrounding the program, issues of reimbursement after a product is approved via the accelerated approval pathway, and learnings from Europe's conditional approval program.

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