By Mark I. Schwartz —
FDA recently published a Federal Register (FR) Notice [Docket No. FDA-2024-N-3945] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.
This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.
“Innovative manufacturing” is a somewhat ill-defined term, but the agency uses it to refer to any novel manufacturing that can increase product development speed, bolster supply chains, or prevent drug shortages. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.
In connection with this effort, on June 8, 2023, FDA participated in a public workshop on the use of innovative manufacturing technologies and discussed potential barriers to their adoption. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.
At the workshop, stakeholders also shared feedback on their interactions with CDER’s Emerging Technology Program (ETP) and CBER’s Advanced Technologies Team (CATT), which were designed to guide sponsors on submissions which incorporate innovative manufacturing technologies.
Based on the exchanges during this workshop FDA developed the draft strategy document which outlines the specific activities FDA intends to undertake to facilitate the use of innovative manufacturing technologies. They include the following:
- Continuing to enhance CDER’s ETP and CBER’s CATT as mechanisms to support innovation.
- Regarding CDER’s ETP, the current ETP guidance document, originally published in 2017, will be updated by the end of 2026, and will include details on communicating the type of products and stages of development for which a requestor can approach the ETP. In addition, by the end of 2026 FDA will issue a report summarizing the activities performed by FDA’s Emerging Technology Team (ETT), which includes relevant representation from all FDA pharmaceutical quality functions. Finally, the ETT will establish program goals and performance measures for the ETP.
- Regarding CBER’s CATT, the center is currently revising its internal procedures, referred to as CATT 2.0, with the goal of providing better service to stakeholders interested in early engagement regarding innovative manufacturing technologies. This will include, by November 2024, a more streamlined process, tracking, more timely review of meeting requests, and communication with requesters by providing periodic updates. In addition, the CATT website will be revised by November 2024 to provide additional clarity about the CATT meeting process, sponsor eligibility, meeting request content, timelines, and potential outcomes of CATT engagements.
- Supporting and utilizing ongoing initiatives for advanced manufacturing to address potential barriers.
- Given that a major regulatory barrier to the adoption of innovative manufacturing is a lack of international harmonization in regulatory requirements, FDA will continue to explore mechanisms for harmonization, including guidances, such as those developed by the International Conference on Harmonization (ICH), and pilot programs such as those created by the International Coalition of Medicines Regulatory Authorities (ICMRA).
- Implementation of the Advanced Manufacturing Technology Designation Program.
- In 2023, FDA published a draft guidance entitled Advanced Manufacturing Technologies Designation Program. It provides recommendations to sponsors interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs manufactured using AMT. The draft guidance outlines the eligibility criteria for AMT designation, the submission and assessment process for requests, and the benefits of an AMT designation. FDA intends to finalize the guidance on Advanced Manufacturing Technologies Designation program by the end of 2024.
