Generics Firms Improved Chances Of Winning Pre-ANDA Meetings For Complex Drugs Last Year
FDA officials said manufacturers of complex generic drugs submitted more approvable requests for pre-submission meetings for FY 2018. Official also clarifies at recent meeting when it's best to request a pre-ANDA meeting and when to submit a controlled correspondence.
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Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
During first half of fiscal 2018, US FDA only granted 16 of 31 pre-ANDA meeting requests, but said it was to ensure meetings were productive.
Agency willing to talk to generic sponsors about complex product issues, but it can avoid the resource-intensive process by updating product-specific development guidances.