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.
You may also be interested in...
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.
ANDA Sponsors Face Tight Controls On Meetings With US FDA After CR Letters
Meetings are intended to help generic sponsors understand deficiencies, but agency won't let them run past 30 minutes.
US FDA’s Pre-ANDA Advice On Correspondence, Meetings And Product-Specific Guidance
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.