The Return Of The Advisory Committee: US FDA Has Busy Fall Ahead

The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.

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For the first time in a while, FDA watchers have a busy upcoming advisory committee schedule. • Source: Shutterstock

Anyone glancing at the US Food and Drug Administration’s website listing upcoming advisory committee meetings is in for something of surprise: there are a ton of meetings planned in October and November.

The agency’s drug and biologic product focused panels are scheduled for no fewer than 10 meetings over the next two months, nine of which focus on specific products. That contrasts...

The variety, along with the sheer number, of meetings stands out. FDA’s advisory committee calendar has been dominated in recent years by two committees: the Center for Drug Evaluation and...

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