CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
Notable Accomplishments
- Published "Distributed Manufacturing of Drugs: Stakeholder Feedback and Action Plan" in November 2023.
- Held the FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing on September 26 – 27, 2023, as a virtual event.
- Published a discussion paper on Artificial Intelligence in Drug Manufacturing for public comment by November 27, 2023.
- Published “Distributed Manufacturing and Point-of-Care Manufacturing of Drugs: Discussion Paper” for public comment in Fall 2022.
- Held the FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing in November 2022.
Advanced manufacturing technologies have the potential to improve the reliability and robustness of the manufacturing process and supply chain and increase timely access to quality medicines for the American public. CDER established the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to prepare a regulatory framework to support the adoption of advanced manufacturing technologies that could bring benefits to patients.
Through its Emerging Technology Program, CDER observed the rapid development of advanced manufacturing technologies across drugs it regulates, including innovator and generic or biosimilar products.
FRAME’s Technology Focus
The National Academies of Sciences, Engineering, and Medicine (NASEM) issued a report identifying innovations CDER is likely to encounter that have the potential to advance pharmaceutical manufacturing. Based on this report and engagements with stakeholders through the Emerging Technology Program, the FRAME initiative prioritized four technologies:
- End-to-End Continuous Manufacturing (E2E CM): A fully integrated process into which raw materials are continuously fed and transformed and finished drug products are continuously removed.
- Distributed Manufacturing (DM): A decentralized manufacturing strategy with manufacturing units that can be deployed to multiple locations.
- Distributed manufacturing units at non-traditional host sites: for example, at healthcare facilities.
- Artificial Intelligence (AI): Software and hardware systems that can perceive the environment, interpret data, and decide actions.
FRAME Priorities
FRAME focuses on four key priorities to develop a regulatory framework for advanced manufacturing technologies:
- Seek and Analyze Input to ensure CDER’s understanding of advanced manufacturing technologies is thorough and its analysis of the regulatory framework is science- and risk-based.
- CDER plans to solicit stakeholder feedback by releasing discussion papers and holding a public workshop on regulatory areas of consideration for advanced manufacturing technologies.
- Address Risks to ensure regulations and policy are compatible with future advanced manufacturing technologies.
- Through FRAME, CDER is evaluating our existing risk-based regulatory framework as it applies to these technologies to enable timely adoption of advanced manufacturing technologies
- Clarify Expectations for stakeholders implementing advanced manufacturing.
- As a result of FRAME, CDER may issue new or updated guidance to explain the current thinking on a regulatory issue.
- Harmonize to ensure global regulatory practice is clear to stakeholders implementing advanced manufacturing.
- The FRAME initiative is aligned with FDA’s efforts to work through the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to develop international guidelines related to advanced manufacturing technologies, such as continuous manufacturing, the subject of a new ICH Q13 guideline.
Publications
Artificial Intelligence in Drug Manufacturing (PDF - 2 MB) open for public comment until November 27, 2023.