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

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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.

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