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FDA asks for comment on AI manufacturing

The Food and Drug Administration (FDA) has published a discussion paper on the use of artificial intelligence (AI) in pharmaceutical manufacturing. The document includes questions to stimulate public feedback, including stakeholders from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The discussion paper presents areas for consideration and policy development identified by the CDER scientific and policy experts associated with the application of artificial intelligence (AI) to pharmaceutical manufacturing. The discussion paper reports, "Advanced manufacturing is a term that describes an innovative pharmaceutical manufacturing technology or approach that has the potential to improve the reliability and robustness of the manufacturing process and resilience of the supply chain.”

The discussion paper is designed to provide information for stakeholders and solicit public comments on a specific area of emerging and advanced manufacturing technologies. The discussion paper defines advanced manufacturing as: "(a) integrate novel technological approaches, (b) use established techniques in an innovative way, or (c) apply production methods in a new domain where there are no defined best practices.”

This latest announcement continues FDA’s attempts to embrace advanced manufacturing. In 2014, CDER established the Emerging Technology Program (ETP) to work collaboratively with companies to support the use of advanced manufacturing. CDER observed a rapid emergence of advanced manufacturing technologies through the ETP and recognised that regulatory policies and programs might need to evolve to enable timely technological adoption.

The pharma industry is now seeing a period of regulators driving the adoption of advanced manufacturing technologies in areas that have seen a relatively slow pace of adoption compared to other laboratory sectors. While AI is continuing to become increasingly ubiquitous in society, highly regulated industries in the lab sector have been slower to adopt new technology.

The FDA website includes several ways to comment and provide feedback on this AI discussion paper.

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