About the Author
Proxima CRO Team
Isabella Schmitt, MBA, 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.

In addition to the general information that should be included in a cover letter for any Q-Sub type to ensure appropriate login and submission tracking, the following information should be included in a SIR:

  • Specific Questions. A SIR should include clear, specific questions regarding review issues relevant to the planned response to the pending marketing submission hold letter (e.g. questions regarding non-clinical and clinical testing protocols or data needed to support the submission), IND Clinical Hold, or IDE letter, including identification of the deficiencies to be discussed, in order to focus FDA and submitter efforts on issues most relevant to moving a project forward.
    If a submitter would like feedback on plans for collection of new data to address a review issue, the submitter should propose a protocol with a rationale for the chosen approach. Note that resource constraints do not permit FDA to prepare or design studies. In addition, requests for a pre-review of data are generally not appropriate for a SIR. However, if data and conclusions are difficult to interpret, it may be appropriate to ask a specific question regarding the interpretation of preliminary results or the planned approach for addressing the results within the upcoming submission.
  • Preferred Feedback Format: In the cover letter, the submitter should specify their preferred mechanism for obtaining FDA feedback: either written feedback or a meeting.

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