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FDA “Program” Reviews Are Positive So Far, But Are They Sustainable?

 
• By Kate Rawson

Early feedback on FDA’s review “Program” for new drugs and biologics is cautiously optimistic. FDA is meeting user fee goals. Communication between reviewers and drug sponsors has dramatically improved. And even trickier applications have done unusually well at advisory committee meetings. But FDA’s John Jenkins acknowledges that a lack of resources is straining the system – and forcing the agency to adapt.

The Food & Drug Administration has the first full calendar year of the new review “Program for Enhanced Review Transparency and Communication” for novel drugs and biologics under its belt, and so far, the results look pretty good:

Of course, almost all of those data points are to some degree misleading: the Program is simply too new for there to be any second-cycle applications

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