This is a ready-to-use log for tracking every review-cycle question received during a submission’s active review, an FDA Information Request or an EMA List of Questions or List of Outstanding Issues. It exists to make sure every question is answered by the right owner, signed off before it goes out, and checked for whether the response risks becoming a major amendment or an additional review round. Replace every <<FILL: ...>> placeholder with your own specifics and route the completed log per your document retention procedure. A worked filled sample row follows.
Purpose
This log tracks every regulatory question received during the active review of <<FILL: submission, e.g. BLA 761XXX>>, from receipt through signed-off response, so nothing is answered late, by the wrong owner, or in a way that is inconsistent with the rest of the application.
Scope
Applies to every Information Request, discipline review letter question, List of Questions item, or List of Outstanding Issues item received during the active review of <<FILL: submission>>.
Field table
| Field | Format | Required | Who records it | When |
|---|---|---|---|---|
| Question ID | <<FILL: format, e.g. IR-2026-014>> | Yes | Regulatory affairs | On receipt |
| Question vehicle | <<FILL: Information Request / discipline review letter / List of Questions / List of Outstanding Issues>> | Yes | Regulatory affairs | On receipt |
| Date received | Date | Yes | Regulatory affairs | On receipt |
| Question text (verbatim or full paraphrase) | Text | Yes | Regulatory affairs | On receipt |
| Module / section referenced | <<FILL: e.g. 3.2.S.2.5>> | Yes | Regulatory affairs | On receipt |
| Named discipline owner | Name/role | Yes | Regulatory affairs, assigned same day | On receipt |
| Response due date | Date | Yes | Regulatory affairs | On receipt |
| Draft response uses existing data only (Yes/No) | Yes/No | Yes | Discipline owner | Before QA review |
| If No, new data or study required | Text | Only if applicable | Discipline owner | Before QA review |
| Major amendment / extra round risk flagged | Yes/No, escalated to whom | Yes | Discipline owner and regulatory affairs | As soon as identified |
| QA sign-off | Name, date | Yes | Quality Assurance | Before submission |
| Regulatory sign-off | Name, date | Yes | Regulatory affairs lead | Before submission |
| Date response submitted | Date | Yes | Regulatory affairs | At submission |
| Clock impact | <<FILL: none / major amendment, 3-month extension / additional question round>> | Yes | Regulatory affairs | After agency acknowledgment |
| Post-approval commitment created by this response (if any) | Text | As applicable | Regulatory affairs | At submission |
Instructions
Assign a named discipline owner the same day a question is received; a question with no assigned owner is the most common cause of a late or rushed response. Before a response is finalized, the discipline owner states plainly whether it uses only data already on file; if new data is required, escalate immediately rather than after drafting, since that determines whether the response can still meet the vehicle’s expected turnaround. Every response gets QA and regulatory sign-off before it is submitted, regardless of how routine the question appears; a technically correct answer that is inconsistent with another section of the file creates a new problem larger than the one it resolves.
Retention
Retain with the submission’s internal regulatory file per <<FILL: site document retention procedure>>, retrievable for the life of the marketing authorization, since a response becomes part of the application and can resurface as context for a future supplement or inspection.
Filled sample row
| Field | Entry |
|---|---|
| Question ID | IR-2026-014 |
| Vehicle | FDA Information Request |
| Date received | 2026-06-12 |
| Question text | Provide the statistical basis for the potency acceptance range stated in Section 3.2.S.4.1 and confirm it is consistent with the range referenced in 3.2.S.2.5. |
| Module referenced | 3.2.S.2.5, 3.2.S.4.1 |
| Named owner | <<FILL: role, e.g. Statistics Lead>> |
| Due date | 2026-06-19 |
| Existing data only | Yes |
| New data required | N/A |
| Major amendment risk | No, existing tolerance-interval analysis already on file addresses the question directly |
| QA sign-off | <<FILL: name>>, 2026-06-17 |
| Regulatory sign-off | <<FILL: name>>, 2026-06-17 |
| Date submitted | 2026-06-18 |
| Clock impact | None, response accepted as a routine clarification |
| Post-approval commitment created | None |
Common findings this log prevents
- A question sitting unanswered for days because no one was clearly assigned to own it.
- A response drafted with new data, unintentionally triggering a major amendment, because the risk was not flagged until after submission.
- A technically accurate response that quietly contradicts another section of the application, because it was never routed through QA and regulatory sign-off.
- No record of what a response committed the company to going forward, discovered only when a post-approval obligation surfaces with no clear origin.
How to adapt this log
- Set the submission identifier and the vehicle types your program actually receives (FDA-only, EMA-only, or both).
- Assign named discipline owners by section of Module 3 in advance, so the assignment step in the field table is instant, not a delay.
- Review the “major amendment risk” column weekly during an active review cycle, not only when a response is finalized.