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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FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates
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.
Pre-ANDA Meetings Proving Tough To Get – Nearly Half Of Requests Denied
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.
US FDA Commits To Meeting With Complex ANDA Sponsors, Works Hard To Avoid It
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.