Approval decisions for the FDA's CNPV pilot program will be made by product center officials, but it's unclear if the responsibility lies with center directors or review office leaders.
Approval decisions under the Commissioner’s National Priority Voucher (CNPV) pilot program will be made by US Food and Drug Administration product center officials, not the commissioner’s office or a multi-disciplinary review council, a staff manual guide states.
However, whether approval decisions will be the responsibility of the drugs and biologics center directors or the review office and...
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
Approval decisions for the FDA's CNPV pilot program will be made by product center officials, but it's unclear if the responsibility lies with center directors or review office leaders.
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
