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BIO Presents Statement at FDA PDUFA 6 Meeting

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On behalf of the Biotechnology Industry Organization (BIO), thank you for the opportunity to provide our comments on the success of the PDUFA program and recommendations to enhance the program through the user fee reauthorization process.</p>

On behalf of the Biotechnology Industry Organization (BIO), thank you for the opportunity to provide our comments on the success of the PDUFA program and recommendations to enhance the program through the user fee reauthorization process.

BIO fully supports timely reauthorization of PDUFA 6. We look forward to working closely with FDA, Congress, and other stakeholders to enhance the program further: to integrate the patient voice into the drug development and evaluation processes most effectively, support FDA’s scientific capacity and infrastructure, and ensure the long term stability of the program.