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FDA Will Allow 10 Minor ANDA Corrections Before Refusing To Receive

 
• By Derrick Gingery

Generic Drug User Fee Act refuse-to-receive draft guidance says FDA will allow sponsors to make a few small fixes to applications, but the agency will not accept any ANDAs with big problems, which will trigger automatic refuse-to-file actions.

FDA will allow up to 10 minor deficiencies before automatically refusing to receive an abbreviated new drug application under an increasingly formalized generic drug user fee submission process.

In a draft guidance on ANDA refuse-to-receive standards issued Sept. 30, FDA said it will work with sponsors...

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