FDA’s Drug Review Challenge For 2013: Managing Sponsor Expectations

The first late-cycle meetings under FDA’s new drug review process are scheduled to start in February, and the agency is scrambling to manage expectations. What agency officials don’t want: a contentious fight over approvability, followed by a flood of new submissions and appeals. Industry’s response: Good luck with that.

If there’s one thing pharmaceutical companies like most about the Food & Drug Administration’s new review process for novel drugs and biologics, it’s the expanded opportunities to communicate with agency officials. Any chance to sit down with an NDA or BLA review team allows more insight and transparency into FDA’s thinking about a pending application and makes for fewer surprises down the road.

Of course, that additional transparency comes with a price: Under the newly reauthorized Prescription Drug User Fee Act, “The Program,”...

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