FDA set to open comments on AI use in pharma manufacturing
The FDA wants to know what people think about the use of AI in the pharma manufacturing space.
According to a public inspection document, the FDA plans to publish a request for information notice on Wednesday, aiming to gather public comments on “emerging and advanced” manufacturing tech, specifically in artificial intelligence’s use in pharma manufacturing.
The paper will lay out “areas for considerations and policy development” from the Center for Drug Evaluation and Research (CDER) surrounding AI in pharmaceutical manufacturing. The paper is meant to encourage and gather feedback from the public, people in the industry, as well as CDER and the Center for Biologics Evaluation and Research (CBER).
The document also says:
This discussion paper presents areas associated with the application of AI to pharmaceutical manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework. CDER scientific and policy experts identified these areas from a comprehensive analysis of existing regulatory requirements applicable to the approval of drugs manufactured using AI technologies.
Some areas the FDA is hoping to receive commentary around include any possible difficulties that may come about in applying current regulations to AI or any issues surrounding a lack of guidance or experience.
The discussion paper was released on Wednesday and covered several subjects related to AI in manufacturing. This included cloud applications for data, wether more clarity is needed about how AI is subjected to regulatory oversight and the need for validating AI models.
The FDA has already produced some guidance in the use of new technologies or techniques in the pharma manufacturing process. In 2014, CDER created the Emerging Technology Program, or ETP, to work with companies that were starting to use more advanced manufacturing techniques and overall technology.
While no guidance specific to AI use in pharma manufacturing has been developed yet, there has been guidance surrounding the proper use of machine learning and AI in medical device development in 2021, as well as other guidance surrounding AI in devices. The FDA does have other guidances for advanced manufacturing, mainly centered around continuous manufacturing. A discussion paper was also written last year on point-of-care manufacturing.
Editor’s Note: This story has been updated with more information from the discussion paper released by the FDA.