Here is what I think is going on- hopefully the damn...

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

• Division of Cell Therapy 1
  • Cell Therapy Branch 1
  • Cell Therapy Branch 2
  • Cellular and Tissue Therapy Branch

1. What is the structure of the new OTP?
   • The Office of Tissues and Advanced Therapies (OTAT) was reorganized to become the Office of Therapeutic Products (OTP) and transitioned into a super office structure. New offices created within the super office structure align disciplines and product types, allowing our workforce to address the exponential growth in cell and gene therapies. This updated structure will enable OTP to:
     • Provide oversight and coordination across programs
     • Ensure flexibility for current and future growth in staff
     • Distribute workload more evenly
     • Support industry needs and commitments
     • Enhance expertise in highly specialized disciplines
   
   
2. Within OTP, six (6) Offices have been established:
   • Office of Gene Therapy Chemistry, Manufacturing, and Controls (CMC)
   • Office of Cellular Therapy and Human Tissue CMC
   • Office of Plasma Protein Therapeutics CMC
   • Office of Clinical Evaluation
   • Office of Pharmacology/ Toxicology
   • Office of Review Management and Regulatory Review

1. 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.

1. Will there be changes to CBER’s Standard Operating Policies and Procedures (SOPPs) as well as guidance documents related to INDs and marketing applications?
   • CBER SOPPs and guidance documents related to INDs and marketing applications may be updated as a result of the reorganization to reflect new organizational titles and processes. CBER and OTP have a team dedicated to administrative activities. Consistent with our good guidance practices, we welcome comments on our guidance documents. Updated documents and policies and procedures will be posted on the FDA website
   REG