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Home » Revised GDUFA Guidance Clarifies Packager and Fatal Flaw Definitions
Revised GDUFA Guidance Clarifies Packager and Fatal Flaw Definitions
September 24, 2013
Companies that package an approved ANDA product for the first time are classified as a packager subject to GDUFA’s facility fees, the FDA says in newly revised GDUFA question-and-answer guidance.