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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

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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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