Priority Review Vouchers: Does Novartis Have User's Regret?

Stakeholders are sympathetic to FDA's concerns that voucher program requires diversion of precious resources, but some believe it provides substantial drug development incentive, particularly for small companies.

Thought needs to be given to how to blunt the impact of the rare pediatric disease priority review voucher program on FDA's drug review operations, pharma company and patient advocacy group representatives suggested at the recent World Orphan Drug Congress USA in Washington, DC.

During a panel discussion on legislation to renew the voucher program, it was clear that industry and rare disease advocates...

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