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A new FDA guidance for industry describes how to comply with the annual self-identification and user fee requirements contained in the Generic Drug User Fee Amendments of 2012 (GDUFA). The guidance addresses: ● which types of generic facilities, sites, and organizations are required to self-identify ● what information is requested ● the technical standards for electronically submission ● the penalty for failing to self-identify, and ● who is required to pay user fees.
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Inside the Global Regulatory Dialogue
