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.
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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.
Meetings are intended to help generic sponsors understand deficiencies, but agency won't let them run past 30 minutes.
OGD's Lionberger offers advice on when to request a pre-ANDA meeting instead of controlled correspondence – and on the pros and cons of waiting for the agency to update product-specific guidance with the latest approaches.