The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Tissues and Advanced Therapies (OTAT) launches new webpage, Interactions with Office of Tissues and Advanced Therapies | FDA
This new content provides stakeholders with resources and accessible information on INTERACT and PDUFA meetings to foster productive engagement with OTAT and advance development of the products that OTAT regulates, including cell and gene therapies. The webpage helps translate complex regulatory terminology and the multiple PDUFA meeting types and timelines, and clarifies expectations of both OTAT and sponsors.
Topics addressed include appropriate timing for specific meetings during development, procedures for requesting meetings, scheduling timelines, common reasons meeting requests are denied, considerations when preparing briefing packages, examples of questions that are appropriate, examples of questions that are not appropriate, best practices for conducting the meeting, meeting minutes, and the Written Response Only (WRO) clarification process. Considerations are specific to OTAT-regulated products.
OTAT intends to update the webpage intermittently, as needed, to reflect changes in processes.
This webpage is one of several tools OTAT is creating to improve communications with stakeholders while increasing capacity and efficiency in OTAT operations.
Visit website here: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/interactions-office-tissues-and-advanced-therapies