Lifecycle of an ETP Technology
The Emerging Technology Program serves as an entry point for new technologies that will potentially be included in a regulatory filing for a specific drug product. As industry develops new technologies, they can reach out to ETP and request input and feedback on an emerging technology. To participate in the program, industry members can submit a written request and proposal as outlined in the Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry.
If accepted into the program, Emerging Technology Team (ETT) members will work with industry and sponsors to discuss, identify, and resolve technical and regulatory issues related to the development and implementation of the novel technology. This process includes meetings between industry sponsors and ETT members, site visits, and ETT participation in quality assessment of regulatory submissions and pre-approval or pre-license inspections.
Once ETP has gained significant experience assessing a technology and the technology has been approved in multiple regulatory applications, the program may decide to graduate the technology and transfer the review of future applications to the standard quality assessment process. To facilitate this transfer, ETT members apply their knowledge and experience to train and provide guidance to FDA reviewers on the technology. Through graduation, FDA indicates confidence that industry’s quality (CMC1 ) submissions related to the technology require little input or guidance from ETT members. By graduating technologies out of the program, ETP creates capacity to accept future emerging technologies to keep pace with industry innovations.
Recently, ETP has graduated its first technology – Continuous Direct Compression (CDC). To learn more about CDC, the criteria for what portions of CDC qualify for graduation, and what ETP has done to support this milestone, please read ETP’s CDC Graduation Announcement.
1Chemistry, Manufacturing, and Control