Insights

More Articles Back to Article

Perspectives on FDA’s Accelerated Approval Program

While it is clear that FDA and drug sponsors must work together to proactively plan and diligently implement clinical trials for the collection of data sufficient to “convert” accelerated approval into traditional approval, equally important is ensuring that while clinical trials are pending, patients who receive AAP-approved drugs in the clinical setting fully understand the program, its limitations, and the tradeoffs they are making.