Frequently Asked Questions

What content and review process are expected for an Informational Meeting?

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There is no specific additional information requested for Informational Meeting requests beyond the general information that should be included in a cover letter for any Q-Sub type to ensure appropriate login and submission tracking. As Informational Meeting requests maybe used for multiple purposes, submitters should consider any additional information relevant to the goals of their submission.

There is no Acceptance review for an Informational Meeting. FDA aims to hold an Informational Meeting within 90 days of receiving the submission, as resources permit.