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Patient-Focused Drug Development, Complex Trial Design May Not Get More Funding In PDUFA VII

 
• By Derrick Gingery

US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.

Clinical Trial
Changes to the FDA's Complex Innovative trial Design (CID) program may be coming in PDUFA VII. • Source: Shutterstock

Drug sponsors balked at increasing user fee funding for the Patient-Focused Drug Development and Complex Innovative trial Design programs, questioning the additional staff proposed to maintain and expand them.

Members of the prescription drug user fee reauthorization negotiating teams are finalizing language for the commitment letter that would extend the program another five years. (Also see "PDUFA Renewal Negotiations Nearly Complete, With CBER Slated For Major Resource Increase" - Pink Sheet, 19 February, 2021

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