FDA seeks input on its innovative manufacturing technology strategy

The US Food and Drug Administration (FDA) on Wednesday released a draft of its strategic plan to promote the uptake of innovative manufacturing technologies for drugs and biologics.
 
The plan fulfills a mandate of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals for Fiscal Years 2023-2027 (PDUFA VII) to advance the implementation of innovative manufacturing. It was prompted by the feedback the agency received at its 8 June 2023 public meeting on the use of innovative manufacturing technologies for products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), as well as the barriers impeding their adoption.
 
The document also details new milestones and procedures for the agency’s Emerging Technology Team (ETT) and Advanced Technology Team (CATT), as well as issuance of a finalized guidance on its Advanced Manufacturing Technologies Designation Program (AMTDP) by the end of 2024. (RELATED: FDA guidance details new advanced manufacturing technology designation program, Regulatory Focus 14 December 2023)

 
Stakeholders have previously raised concerns about long review times for their products by the ETT and CATT. They have also cited differing international regulatory requirements affecting innovative manufacturing technologies as a hurdle to their adoption.
 
To address these concerns and to bolster industry adoption of innovative manufacturing technologies, FDA laid out several steps it plans to take in the draft strategy document.
 
These steps include updating the agency’s 2017 guidance on the emerging technology program (ETP) by the end of 2026. The update will include details on communicating the type of products and stages of development for which a requestor can approach the ETP for acceptance.
 
The agency also said it will issue a report summarizing the activities performed by the ETT by December 2026; this report will cover meetings with representatives of industry, academia, and federal agencies.
 
Additionally, the ETT will establish program goals and performance measures, which include routine monitoring of technologies for readiness and graduation from the ETT, participating in at least five public industry engagements and one international health authority engagement, monitoring user fee goals to ensure they are met for participating applications, ensuring adequate training opportunities are available for ETP staff, and selecting at least intramural topics for the Office of Pharmaceutical Quality Research each year.
 
CBER is also revising its internal procedures to provide “better service to stakeholders interested in early engagement.” As part of this process, CBER will develop a revised process for the CATT program to streamline the process and provide efficiencies to track meeting requests and communicate with requesters by providing periodic updates. This will be completed by November 2024.
 
The agency plans to develop a training program for the International Council for Harmonisation (ICH) working groups on ICH Q5A(R2), viral safety considerations for continuous manufacturing of biologics, in collaboration with ICH, by December 2024. In addition, FDA eill continue to support ongoing initiatives, such as the FRAME initiative, for prioritized advanced manufacturing technologies.
 
Stakeholders have 60 days to comment.
 
Strategic plan; Notice