Generic Industry Consolidating But Still Mysterious
Executive Summary
Nearly 2,000 ANDAs remain unclaimed as US FDA begins fee calculations for GDUFA II.
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FDA Reports Millions In Unpaid GDUFA Fees
The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.
US FDA Reports Millions In Unpaid GDUFA Program Fees
The $20m in generic drug user fee receivables was 12% of the estimated total to be collected in 2018.
FDA Obscura: GDUFA Fee Calculations Took CBER-Regulated ANDAs Into Account
ANDAs regulated by the US FDA's biologics center, some pre-1984 conditional approvals, and others were factored into GDUFA program fee calculations.
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