NDA Annual Reports are due within 60 days after the reporting period ends and FDA won't acknowledge, approve or respond.
I thought CBE-0 and CBE-30 supplements have a 6-month review clock although you can implement the changes immediately for CBE-0 and after 30 days for a CBE-30, but formal approval won't be received until 6 months.
PAS have 6-month review for efficacy supplements, but only 4 months for CMC so that may be why you are hearing both 4 and 6 months.
Information Requests (IRs) from FDA typically include a date that FDA wants a response by.
Protocol submissions to INDs typically don't warrant FDA response unless you specifically request. I don't believe FDA is held to any formal PDUFA review clock, but if you request feedback I think 1-2 months is typical (others with more experience may comment otherwise). The initial protocol in your original IND gets a 30-day review with the entire IND before you can proceed to starting the study. FDA will issue a May Proceed Letter for the original IND as long as they have no issues.
A formal Special Protocol Assessment (SPA) submission is a 45 day review.
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Tom
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 28-Jun-2019 10:41
From: Masa Razic
Subject: FDA action dates
Hi Regulatory family,
Happy Friday!!!
Can anyone help with the FDA action dates on the following submissions:
Annual report, CBE-0, CBE-30, PAS, OPDP, ODD, IR's, LDR, PADER, Draft/Final protocols.
In other words, when can I expect from the FDA to hear back regarding my submission.
By reading the guidance, CBE-0 and CBE-30 FDA has 1 year to respond. For PAS is 6 months. Attending some of the FDA conferences people mentioning for PAS, FDA action date would be 4 months after submission-when initial FDA review is done. SO ai ma very confused on when is the initial review done vs approval/reject of the submission.
I would really appreciate your help for any of these submissions,
Thank you,
Masa
Maša Razić Regulatory Affairs Specialist
PARTNER THERAPEUTICS