Here is what I think is going on- hopefully the damn announcement drops right after I send this...........
CDER guidelines are 30 days turnaround time since 2015 - CBER is 14 days as at Nov 2022.
We now have the OTP - new super office- with divisions that handle cellular technology. Their latest guidelines are March 2023.
Below mentions submissions being rerouted through to OTP.
My view is that the review period is within 30 days not 14 days- Guidelines need to be updated- particularly and specifically for the new Super Office.
So around 7-8th August is the end of the within 30 day review period.
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/establishment-office-therapeutic-products
Office of Cellular Therapy and Human Tissue CMC
- What is the structure of the new OTP?
- Within OTP, six (6) Offices have been established:
- How do the new structural changes impact current processes and communications between sponsors and FDA?
- The first point of contact will remain the regulatory project manager (RPM) previously assigned to a submission and each letter a sponsor receives will continue to identify that point of contact. CBER will update its website to reflect the new organizational leadership and provide additional contact information.
- Submissions will be routed within OTP to ensure they are sent to the appropriate office in the new structure.
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