On March 1, 2023, the United States Food and Drug Administration’s Center for Drug Evaluations and Research (CDER) released a discussion paper on the application of artificial intelligence (AI) in drug manufacturing (the Paper). The Paper identifies areas of consideration for public input and CDER welcomes feedback from stakeholders to assist in the evaluation and development of policy in the space.
In the Paper, CDER discusses the broad potential for using AI in the pharmaceutical industry, including in the optimization of process design and process control, smart monitoring and maintenance of equipment, and monitoring trends and feedback to facilitate continuous improvement in manufacturing operations. CDER also sees the capability of AI being used in conjunction with other innovative pharmaceutical manufacturing technologies to achieve desired benefits.
The Paper focuses on drug manufacturing products that can be marketed under a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA). CDER presents readers with a series of questions that focus on the following five key areas of consideration:
Stakeholders can provide feedback on the Paper until May 1, 2023. More information on the feedback submission process can be found here.
Summary By: Imtiaz Karamat
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