FDA finalizes expedited approval guidance

Final (see BioCentury Extra, July 31, 2013).

The final guidance now includes language that states that FDA may consult with external experts on surrogate or intermediate clinical endpoints to support accelerated approval for diseases with limited historical data. The final guidance no longer includes language noting that an endpoint that "has failed to predict clinical benefit in a properly designed trial for a drug in the same pharmacologic class, or in the same disease or a related disease," would weigh "against reliance on the endpoint as a basis for accelerated approval." ...