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FDA Priority Review Voucher Guidance Coming: Incentive Has Low Visibility

Executive Summary

FDA is planning a public meeting to discuss the new priority review voucher system to begin implementing the new program

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FDA Mulls “Fast Track” Approach For Priority Review Voucher Eligibility

FDA should consider setting up a process to pre-determine whether a product being developed for a neglected tropical disease will qualify for a priority review voucher, BIO Ventures for Global Health VP-Strategy & Operations Wendy Taylor said Dec. 12 at a public hearing convened by the agency

FDA Mulls “Fast Track” Approach For Priority Review Voucher Eligibility

FDA should consider setting up a process to pre-determine whether a product being developed for a neglected tropical disease will qualify for a priority review voucher, BIO Ventures for Global Health VP-Strategy & Operations Wendy Taylor said Dec. 12 at a public hearing convened by the agency

Priority Review Vouchers One Step Closer, But Congress Must Act Again

FDA will not be able to review applications covered by a priority review voucher until it receives Congressional authorization to collect a special user fee to support the program, the agency says in a draft guidance on the new incentive for pharmaceutical companies

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