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FDA Shutdown Hangover Hurts Biosimilars, May Benefit Some ANDAs

 
• By Brenda Sandburg

As normal operations – and normal budget worries – resume, the agency has some meetings to reschedule.

The 16-day closure of the federal government did not visibly hurt drug sponsors as the agency was able to continue reviewing pending applications and even issued a flurry of new drug approvals. But companies pursuing biosimilars will face delays as the agency is extending the goal dates for INDs and advisory meetings. And sponsors with products in the earlier stages of review may have to wait longer for meetings with FDA staff.

During the shutdown the agency did not accept NDA and ANDA submissions that required a user fee payment and it...

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