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.
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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.
The meetings are tied to requirements from the 2016 21st Century Cures legislation. They could offer more development certainty for sponsors by allowing informal agreements with the agency on pre- and post-market issues.
Cures legislation offers more development certainty for sponsors by allowing informal agreements with the agency on pre- and postmarket issues.