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What is the typical review process of a SIR?
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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 Acceptance review for a SIR. Feedback will be provided either in the form of a written response, or a meeting. In the spirit of the MDUFA Shared Outcome goals for Total Time to Decision on most marketing submissions, FDA is committed to resolving review issues promptly and will place added emphasis when Industry similarly works expeditiously to address such issues. Accordingly, FDA intends to prioritize review of SIRs submitted within 60 days of the marketing submission hold, IND Clinical Hold, or IDE letter. This allows FDA to leverage the familiarity with a recent review without the need to re-review the issues. This also incentivizes prompt resolution of issues by both FDA and Industry in order to achieve the MDUFA Shared Outcome goals for Total Time to Decision. FDA intends to provide feedback (either via written feedback or through a meeting, at the request of the submitter) according to the timelines below, to the extent resources permit.

  • Submission Issue Request A: If a Submission Issue Request is received within 60 days of FDA’s marketing submission hold, IND Clinical Hold letter, or IDE letter, the FDA team will aim to provide feedback within 21 days, as resources permit.
  • Submission Issue Request B: If a Submission Issue Request is submitted more than 60 days after FDA’s letter, FDA will aim to provide feedback within 70 days, as resources permit.

If a meeting is held to provide feedback, the submitter is responsible for providing meeting minutes.

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