Purpose: The CATT was established to promote dialogue, education, and input among CBER staff and between CBER and prospective innovators/developers of advanced manufacturing technologies. As part of these efforts, CBER is providing an interactive mechanism for prospective innovators/developers of advanced manufacturing and testing technologies to discuss with CBER staff issues related to the implementation of these technologies in the development of CBER-regulated products.
Scope: The CATT will facilitate discussion of, and responses to, inquiries or meeting requests pertaining to advanced manufacturing technologies that are intended to be implemented in the development of products regulated by CBER. Inquiries or meeting requests submitted to the CATT should focus on novel technologies that can have a significant impact on product development, manufacturing process and control strategies, and 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 brief description of the technology or product class
- A brief explanation why the technology or product class is substantially novel and unique
- A description of the of the impact of the technology or product class in terms of improved biologic product manufacturing, characterization, quality, safety, or efficacy
- A summary of the manufacturing or development plan and any questions regarding perceived regulatory, technical, or other challenges for implementation