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Agnes Shanley is senior editor of Pharmaceutical Technology.
FDA’s Emerging Technologies Team (ETT) team chair Sau Lee describes the reasons for the team and its structure.
FDA established an Emerging Technologies Team (ETT) in 2014, to optimize decisions about technologies that haven’t been widely used in the industry previously. The team can help companies considering the use of a new technology, and also serves as a resource for inspectors and reviewers within the agency who may be unfamiliar with a new technology. Team chair, Sau Lee, describes the reasons for the team, and its structure.
PharmTech: Which specific technologies is the team focusing on?
Lee: The ETT does not identify technologies a priori. Technologies under consideration are based on industry applications to the Emerging Technology Program. Applications to the program are evaluated to assess whether the proposed technology has the potential to improve product safety, identity, strength, quality, or purity, or whether the technology includes one or more elements subject to quality assessment for which the agency has limited review or inspection experience.
PharmTech: When would a company get in touch and how? And how does the team interact with review and inspection departments?
Lee: The Emerging Technology Program takes a collaborative approach to engagement on the topic, both internally and externally. The ETT’s chair and members are drawn from across FDA and bring a wealth of technical expertise, regulatory insight, and institutional knowledge and experience to the group.
Industry participants in the program work with ETT early in the technology development process, discussing progress and challenges and addressing technical and regulatory concerns in advance of submitting a drug application for FDA’s evaluation. They benefit from the program by drawing upon FDA expertise and resolving many questions prior to submitting an application. FDA benefits by learning about a new technology in advance of its first appearance in an application for review and inspection, and the public will benefit through improved access to high-quality medications.
In order for the ETT to ensure consistency, continuity, and predictability in review and inspection-based science, the team engages in many facets of product development and submission of a marketing application. It starts with early engagement in the pre-submission phase.
A key opportunity for pre-submission engagement, in addition to face-to-face meetings, is the pre-operational visit. This provides a venue to cover technical and facility aspects in more detail and enhances shared learning and communication. During the assessment of the regulatory application, the ETT member will serve as the co-lead for the assessment, ensuring continuity from the pre-submission phase. Finally, ETT is also involved in the pre-approval inspection which is conducted by team members from FDA’s Office of Pharmaceutical Quality and Office of Regulatory Affairs.
PharmTech: What response have you seen from industry so far?
Lee: Industry has started to be more engaged and open to FDA regarding innovative technologies under the Emerging Technology Program. We have seen an increasing number of industry proposals requesting participation in the program.
PharmTech: What is the team doing to help with reviews of post-approval changes?
Lee: ETT is involved and helps with the review when the change involves the implementation of a new technology that meets the program’s criteria. A good example is the approval for switching from a batch to a continuous manufacturing process in April 2016 for an FDA-approved HIV drug, Prezista. The change was requested in a supplement that was reviewed and approved in less than four months.
PharmTech: What are the plans for the team, both short- and long-term?
Lee: In the short-term, ETT will continue to work with industry to implement emerging technologies, and internally, to strengthen the program management and our internal research program to support the increasing ETT workload and requests for participation. In the long-term, ETT will be engaging regulatory agencies in other countries to help promote international cooperation.
Article DetailsPharmaceutical Technology
Vol. 41, No. 8
When referring to this article, please cite it as A. Shanley, “Inside FDA’s Emerging Technologies Team with Team Chair, Sau Lee,” Pharmaceutical Technology 41 (8) 2017.