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Scrap Citizen Petition Proposal For 505(b)(2), Off-Patent Industry Urges FDA

Citizen Petitions Can ‘Languish Unanswered’ For Years

Executive Summary

Several stakeholders across the off-patent industry, including trade groups and manufacturers, have encouraged the FDA to scrap its proposal to require companies to submit citizen petitions for requesting therapeutic equivalence evaluations for 505(b)(2) applications.

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