CATT Program
Purpose: The CATT was established to promote dialogue, education, and input among CBER staff and between CBER and innovators or developers of advanced manufacturing technologies. As part of these efforts, CBER provides an interactive opportunity for staff to have meetings with innovators or developers of advanced manufacturing and testing technologies to discuss issues related to the implementation of these technologies in the development of CBER-regulated products.
Scope: The CATT will facilitate discussion of inquiries and meeting requests pertaining to advanced manufacturing technologies intended for implementation in the development of products regulated by CBER. Inquiries or meeting requests submitted to the CATT should focus on novel technologies that could have a significant impact on product development, manufacturing process and control strategies, and application of these technologies may also have regulatory implications. This includes manufacturing and analytical methods for those products or classes of products for which the Center has limited experience with the manufacturing or development process.
Process for submitting inquiries/meeting requests to CATT
All requests should be submitted electronically to Industry.Biologics@fda.hhs.gov and include CATT in the subject line. In addition, the request should also include the following information and should not exceed two pages, including figures and tables:
- A summary or description of the technology, product class, and/or manufacturing modality and process with sufficient for CATT to develop responses to questions raised by the requestor.
- An explanation of why the technology or product class is substantially novel and unique relative to existing approaches.
- A description of the impact of the technology or product class in terms of improved biologic product safety, identity, strength, quality, purity, or availability through enhanced manufacturing, testing, and/or control.
- A summary of the manufacturing or development plan, including the status of technology development and plans for implementation or other anticipated modifications.
- A list of specific questions regarding perceived regulatory, technical, or other challenges for implementation.
- Information on any prior communications or engagement with FDA (including meeting type and tracking number if applicable).
- An anticipated timeline for the submission of an INTERACT meeting, pre-IND meeting, or a drug master file, if applicable.
CATT Meeting Request Review Timelines and Outcomes
A prospective sponsor or technology developer submits a request for a CATT meeting to discuss technical and regulatory issues associated with the implementation of a technology in the manufacture of CBER-regulated products. Once the request is received, CATT will evaluate it to determine whether a meeting is warranted to address the questions submitted in the meeting request. Typically, the requestor will be notified within 6 weeks from the date the meeting request was received if a meeting is granted. If the meeting is not granted, CATT may provide feedback on the information submitted and, if appropriate, on the questions submitted with the requests. CATT may also recommend that a different meeting type (e.g. INTERACT or pre-IND) may be more appropriate to properly address the submitted questions. If a meeting is granted, the requestor will be asked to submit additional information (up to 5 pages) to include substantive technical details and information (e.g., requestor’s position and justification for each question) to support CATT responses to the proposed questions. The requestor will also need to provide a copy of the slide deck to be presented during the meeting, as well as a proposed agenda for the meeting. Once this information is received by CATT, the meeting will be scheduled within 90 days based on availability.
CATT meetings are informal and therefore, advice provided by CATT is non-binding. CATT does not draft meeting minutes for these meetings. The meeting requestor may provide a copy of their meeting minutes for reference. CATT meetings are often held virtually via teleconference and are not recorded, although in person meetings may be considered upon request.
