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ANDA Sponsors May Need Extra Three Months To Avoid DMF-Related Delays

 
• By Derrick Gingery

Under GDUFA, drug master files must pass a completeness assessment before they can be referenced in an ANDA. Sponsors should coordinate better with DMF holders to assure that FDA has adequate review time.

Inadequate communication between ANDA sponsors and drug master file (DMF) holders could create a chain reaction of delays under the new generic drug user fee program.

Because ANDAs must now have DMFs deemed complete on submission, DMFs have to clear their completeness assessment before the ANDA can be submitted, potentially lengthening submission review times or forcing...

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