FDA looks to clarify confirmatory trial mandate for accelerated approvals

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory trials at least be underway at the time of these conditional nods. But, after hearing some mixed messaging from the agency, drugmakers were left wondering what exactly “underway” means in this context.

Now, a new draft guidance document tries to clear the air on the agency’s interpretation of the term “underway.”