Question 19 of 20 Advanced Interpretation
How would you interpret a complete response letter and plan the resubmission?
Short answer
A complete response letter means FDA will not approve the application in its current form and lists the deficiencies. Sort them by whether they need new data, new analyses or only documentation, because that decides the class of resubmission. Under PDUFA VII, FDA aims to act on Class 1 resubmissions within 2 months and Class 2 within 6 months.
Why
Under 21 CFR 314.110, the applicant must resubmit, withdraw or request an opportunity for a hearing. If it does nothing within 1 year, FDA may treat that as a request to withdraw, unless an extension was requested. The letter usually separates deficiencies about clinical evidence, manufacturing and facilities, and labeling.
Reading it well means asking what each deficiency really requires. A request for a new adequately controlled trial is a program-level decision that takes years. A request to resolve facility inspection findings depends on a manufacturing site, possibly a contract manufacturer.
A request for additional analyses of existing data may be quick. Class 1 resubmissions cover minor items such as labeling or safety updates, and most others, including new clinical data, are Class 2. An end of review meeting with FDA is often the best next step, to confirm what would make the application approvable.
The team then builds a plan with timelines, owners and a decision on whether the investment is still worth it.
A strong answer covers
- Meaning of a complete response letter
- Options: resubmit, withdraw or request a hearing, with the 1 year rule
- Sort deficiencies by type of fix
- Class 1 at 2 months and Class 2 at 6 months
- End of review meeting to confirm the path
Common mistakes
- Reading a complete response letter as a final rejection.
- Resubmitting without confirming with FDA what would resolve the deficiencies.
- Assuming every resubmission qualifies for the 2 month review.
The interviewer might ask next
How would a facility inspection deficiency at a contract manufacturer change your resubmission plan?