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FDA Guidance Addresses Self-Identification, Facility Payments Under GDUFA

 
• By Joanne S. Eglovitch

An FDA guidance addresses which types of facilities must self-report under GDUFA and pay the facility fee and which facilities must just self-report. Guide also covers whether two separate locations of the same company have to pay a user fee.

FDA issued guidance in a question-and-answer format on July 25 that addresses which types of generic drug manufacturers must self-report under the Generic Drug User Fee Act and pay facility fees, and which facilities need only self-report. The guidance also addresses what is considered a “fatal flaw” that can terminate inspections of generic drug facilities.

The document is titled “Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance.” Previous drafts...

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