Companies can use FDA’s expedited review programs to enhance their regulatory strategies and reduce the time-to-market for their new products. This session covers the expedited review programs for drugs, including the latest developments with the Commissioner’s National Priority Voucher (CNPV) program.

Topics of discussion include:

• Criteria for the CNPV, Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track programs
• Recent developments with the CNPV Program
• Key considerations for companies before seeking expedited review