Log: Information Request / Discipline Review Letter Response Tracker

This is a ready-to-use log for tracking information requests (IRs) and discipline review letters (DRLs) received during health authority review of a marketing application or a supplement. It exists because IRs are easy to treat casually, short deadlines, an informal-feeling email, and treating one casually is exactly how a minor clarifying question turns into a documented deficiency. Keep one log per active application. Replace every <<FILL: ...>> placeholder. A field guide and a filled specimen follow. Read alongside managing health authority interactions for the reasoning behind treating every IR as a reviewed, on-the-record response.

Why this log exists

Every IR response becomes part of the review record, whether it is two sentences or two pages. A team without a single tracked list of open IRs risks three failure modes at once: a deadline missed because no one owned it, a response that went out without quality or regulatory review touching a CMC or data-integrity statement, and a pattern of small, rushed answers that individually look fine but collectively signal a program that is not in control. This log makes every IR visible, owned, and reviewed before it leaves the building, and gives the team a single place to see whether informal review pressure is building toward a deficiency.

Field table

Tracker table

Instructions

1. Log every IR or DRL the same working day it is received, before anyone starts drafting a response. An IR that exists only in someone’s inbox is an IR the program cannot see.
2. Confirm the deadline against the actual letter, not a verbal summary, and flag anything under <<FILL: number>> business days to the regulatory lead immediately.
3. Assign a named owner, not a function or a department. A response with no named person behind it does not get written on time.
4. Route every response touching CMC, validation, data integrity, or facility status through QA review before regulatory submits it. A rushed or inaccurate answer on these topics is the most common way a small question becomes a deficiency.
5. If the deadline cannot realistically be met, negotiate an extension with the regulatory project manager before the deadline passes, and log the negotiated date; do not let a response go silent and log itself as “late” after the fact.
6. Close the outcome field only once the agency’s reaction is known, whether that is silence read as acceptance, a follow-up question, or the issue reappearing in a later communication.
7. Review the open rows at a standing cadence (<<FILL: weekly during active review>>) so a cluster of IRs on the same topic is caught and escalated rather than answered one at a time as if unrelated.

Retention

Retain this log for the life of the application plus the applicable records-retention period in your jurisdiction. Confirm the retention period against <<FILL: records retention SOP>>. Keep the log in a controlled, queryable system rather than a personal spreadsheet, so it survives a change in regulatory personnel.

Acceptance criteria

• Every IR and DRL received appears in the log the same working day, with a deadline and a named owner.
• No CMC, validation, data-integrity, or facility-status response left the organization without a documented QA and regulatory sign-off.
• No deadline was missed without a documented, timely extension request.
• A cluster of related IRs was identified and escalated, not answered as isolated questions.
• The outcome field is current for every closed row, so the team can see whether IR responses are actually resolving reviewer concerns or generating follow-ups.

Filled specimen

Illustrative entries for an example BLA under active review. Replace with your own.

The value shows in IR-2026-044: because the response was logged, QA-reviewed, and tracked, the team caught that the answer as drafted described only the cited batch, and the follow-up question the agency then asked (the full 12-month population) was exactly the kind of scope expansion the CRL resubmission plan template is built to handle if it later becomes a facility deficiency rather than staying at the IR stage. Logging IR-2026-047 as still in QA review, rather than letting it sit in an inbox, is what keeps a five-day statistics deadline from being missed.

Common inspection findings this log prevents

• An IR response that went out with no QA review, later shown to be inconsistent with the batch record or the underlying data.
• A missed IR deadline discovered only when the agency’s next communication referenced it as unanswered.
• A pattern of related IRs on the same underlying issue, answered individually with no one noticing the pattern until it became a deficiency.
• A negotiated extension that exists only as an email thread, with no record in the application’s regulatory history.

How to adapt this log

1. Set your ID scheme and point the retention line to your records-retention SOP.
2. If your organization runs multiple applications at once, key the IR numbers by application so the logs do not collide.
3. Add a column for the review discipline’s specific reviewer or division contact if your program interacts with more than one review division.
4. Tie a facility- or data-integrity-flavored IR directly into a CAPA record once it is clear the issue is systemic, rather than letting it live only as an IR response.