FDA Set To Seek Public Feedback on AI Use in Pharmaceutical Manufacturing

Artificial intelligence (AI) in pharmaceutical manufacturing can revolutionize the industry, bringing about greater efficiency, accuracy, and cost savings. However, there are also concerns about the safety and reliability of AI systems, especially in critical manufacturing processes.

The US Food and Drug Administration is interested in hearing public opinion regarding using artificial intelligence (AI) within pharmaceutical manufacturing. According to a publicly released inspection report, the FDA intends to issue a Request for Information notice on Wednesday that seeks comments on “emerging and advanced” production technology focusing on AI’s use in pharmaceutical manufacturing.

The document will present “areas for assessment and policy formation” from the Center for Drug Evaluation and Research (CDER) regarding Artificial Intelligence in pharmaceutical production.

This paper is intended to promote open dialogue and receive input from the general public, those in the field, and representatives of CDER and CBER.

This pa­per looks in­to the use of AI in the pro­duc­tion of phar­ma­ceu­ti­cals and out­lines the as­pects that the FDA has deemed wor­thy of re-evaluation as they weigh their al­ready existing risk-based regulatory framework.

The experts from CDER conducted a thorough investigation of the regulatory rules related to the authorization of drugs created with AI technologies and identified these regions as a result.

The FDA wants to hear people’s thoughts on any potential obstacles that might arise when attempting to implement existing regulations with AI, as well as any issues related to a lack of direction or expertise.

On Wednesday, a discussion paper was released regarding Artificial Intelligence (AI) in manufacturing. It went over topics like cloud applications for data processing, the necessity of providing more insight into AI’s regulatory oversight, and validating AI models.

In 2014, the FDA’s Center for Drug Evaluation and Research (CDER) established the Emerging Technology Program (ETP) to work with companies adopting more advanced manufacturing technologies and methods. This program was created in response to the need for guidance regarding new technologies or techniques utilized in pharmaceutical production.

A specific guidance concerning the utilization of AI in pharmaceutical manufacturing has yet to be created. However, there is guidance regarding the correct use of machine learning and AI in medical device development this year and other directions concerning AI in devices.

The FDA has released guidance concerning advanced manufacturing, primarily focused on continuous production. Additionally, a paper was published last year examining point-of-care manufacturing.

An ed­i­to­r­i­al note has been added to this article, incorpo­rat­ing more data from the FDA’s diFDA’s­sion pa­per.

The FDA’s decision to open comments on AI use in pharma manufacturing is a positive step towards harnessing the power of AI to improve patient outcomes and drive innovation in the industry. All stakeholders need to engage in this process, providing feedback and insights that can help shape the future of pharmaceutical manufacturing. We can build a more efficient, effective, and safe healthcare system for all by working together.

Source: Endpoints News

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