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Another ANDA Submission Surge Begins

 
• By Derrick Gingery

US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.

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FDA began the new fiscal year with another large basket of ANDA approvals, but also saw double that total in submissions. The generic industry, it seems, is very interested in FDA's new 10-month application review goal.

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