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Generic Drug Facilities Guidance Details Who Self-Identifies, And Who Pays Fees

Executive Summary

An FDA draft guidance defines which generic drug manufacturers and other entities must self-report under the new user fee law and which must pay facility fees. It also outlines practical steps companies should take now to meet requirements by deadline.

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API, finished dosage form and other facilities in the generic drug supply chain must submit information to FDA by Dec. 3. As of Nov. 18, about one-third had complied, potentially affecting user fee amounts.

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