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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