The paradigm for accelerated approval confirmatory trials employed by the US Food and Drug Administration’s Oncology Center of Excellence would be extended to non-cancer drugs and biologics in new draft guidance.
Confirmatory Trials: US FDA Toughens Stance On Need For Advance Planning, Due Diligence
Strategies championed by the Oncology Center of Excellence, including early planning and use of a single randomized study to support accelerated approval and later verify clinical benefit, are reflected in a new draft guidance broadly applicable to drugs and biologics.
