Generic Drug Facilities Guidance Details Who Self-Identifies, And Who Pays Fees
An FDA draft guidance defines which generic drug manufacturers and other entities must self-report under the new user fee law and which must pay facility fees.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.
Numbers in some cases are dramatically different from more recent estimates used to calculate user fee amounts. The agency says it wanted the figures to remain consistent with a previous notice that was published before the fees were calculated.
Fiscal year 2013 fees for new ANDAs, prior approval supplements, backlogged applications and drug master files are 3%-50% below the agency’s initial projections.