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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ANDA Submissions Drop To Start FY2021
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
ANDA Submissions Drop To Start FY 2021, Perhaps Forced Down By COVID-19
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.
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.