I agree, the Agency will let you know within 30 days if the have a major safety concern. In my experience, and per FDA MAPP 6030.9, Table 6 last row (https://www.fda.gov/media/85790/download) FDA will complete a development review of a protocol amendment within 60 days. If they have feedback they will let you know. It may differ a bit by review division and team, whether you get any feedback. You can always reach out to the RPM around day 60 to inquire if you can expect feedback.
Regarding the cover letter, you can ask for Agency feedback on a different timeline, but there is no obligation on their end of comply and, given their workload, it is not likely that they will be any faster than per the MAPP. They may of course be slower, thus, again my recommendation to check in with your RPM.
Good luck!
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Anna Sedello, PhD, RAC-Drugs
Senior Director of Regulatory Affairs
Palo Alto CA
United States
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Original Message:
Sent: 13-Apr-2023 11:40
From: Anonymous Member
Subject: Phase 3 Protocol Amendment
This message was posted by a user wishing to remain anonymous
If the FDA thinks (or conveyed at EOP2) there is a safety issue with the expansion of your proposed study population, the Agency will come back within 30 days! Absence of safety, you may or may not hear back regardless of your requested target dates for their feedback (it depends on their busy schedule)
Original Message:
Sent: 12-Apr-2023 10:19
From: Anonymous Member
Subject: Phase 3 Protocol Amendment
This message was posted by a user wishing to remain anonymous
We are amending a Phase 3 protocol to expand the patient population. This was a somewhat contentious discussion at the EOP2 meeting, but we believe this amendment aligns with the feedback we got. What are your thoughts on asking FDA for feedback in the cover letter when we submit this protocol? Something like:
We plan to implement this change to the study immediately and begin enrolling "expanded patient population" patients by xx date. If FDA has any comments, we respectfully request that they be provided by xx date.
vs just submitting the amendment with the little table of changes and remaining silent on requesting feedback, understanding that the Agency can always provide feedback at any random time (even after the study is over, as I'm sure many of us have experienced).