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FDA Web Portal Eases Pre-ANDA Meeting Request Process

 
• By Derrick Gingery

New CDER Direct NextGen Collaboration Portal allows sponsors of complex ANDAs to submit and track formal meeting requests.

CDER Direct Next Gen web page
FDA created a web portal for complex generic sponsors to submit and track pre-ANDA meeting requests.

FDA eased the burden on sponsors to request a formal meeting for a complex ANDA, which conflicts with draft guidance, just as the new system debuted.

Agency officials unveiled a web portal for complex ANDA sponsors to make meeting requests. As of Oct. 1, the CDER Direct NextGen Collaboration Portal allows sponsors to more easily...

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