GDUFA Research Impacting Generic Development, ANDA Approvals
Increases in approved ANDAs that were affected by GDUFA research shows the importance of the US FDA’s regulatory science program.
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Will US FDA User Fee Deal Allow BsUFA Reg Science Research To Start?
The FDA had picked grantees for the initial round of biosimilar regulatory science research, but told them not to start major activities until the user fee reauthorization was assured. Congress now appears to have reached deal for a ‘practically clean’ reauthorization.
Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
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Growing Complex Generic Application Load May Force US FDA Staffing Changes
Complex products are slowly gaining a larger share of ANDA submission and approval totals, which could mean the FDA has to adapt its in-house expertise to compensate.