Adcetris Review Adds Some Clarity To Principles For Accelerated Approval
Sponsors seeking insight into when a single-arm trial will be deemed acceptable support for accelerated approval by FDA and its Oncologic Drugs Advisory Committee can look to the recent review of Seattle Genetics’ Adcetris (brentuximab) for clues.
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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.
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