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‘Breakthrough’ Fee Eyed As Deterrent To Frivolous Requests

Executive Summary

Companies currently face little risk in seeking the designation because there is no financial cost and FDA denial is confidential.

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PDUFA VI: Breakthrough Issues Among FDA Priorities

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Hope is to quickly reject obviously inadequate designation requests, but few meet criteria for dismissal so far.

PDUFA Negotiations Begin With FDA Seeking Review System Reform

During the inaugural negotiating session for renewal of PDUFA, which covers OTC switch and other nonprescription product NDAs, FDA says among its goals are “enhancements to the review processes.” The five-hour session included the ground rules for the talks and FDA and industry representatives also laid out their general wants and needs.

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