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Generic User Fee Renewal Talks Faced 'Buyer's Remorse' From GDUFA I

Executive Summary

Industry dismay at slow pace of ANDA approvals and FDA communications in early years of first user fee agreement factored into GDUFA II negotiations.

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Generic Drug First-Cycle Approval Rates Lagging Under GDUFA I

Only 8% of original ANDAs submitted in the user fee program’s third year were approved on the first cycle, compared with 72% that received a complete response letter.

Complex ANDAs To Be Allowed Pre-Submission Product Meetings

FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.

GDUFA II: Industry Shares Stage With FDA

Public meeting departs from usual format, allowing industry representatives to sit next to FDA and answer audience questions as generic during user fee agreement outlined.

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