Drugs

CDER Creates Internal AI Council

CDER director Patrizia Cavazzoni has announced the creation of a CDER Artificial Intelligence (AI) Council to “provide oversight, coordination, and consolidation of AI activities.” In an announcement to Center staff, Cavazzoni says the new council will consolidate and continue the work started by the CDER AI Steering Committee, AI Policy Working Group, and CDER AI Community of Practice, all of which will sunset.

She says the new council will coordinate, develop, support, and promote consistency of both internal and external AI-related activities in CDER and, as appropriate, oversee activities including the Center’s internal AI capabilities and AI policy initiatives for regulatory decision-making. The council also is to:

be the focal point for innovation to help expand the appropriate use of AI in CDER;
ensure that CDER speaks with a unified and consistent voice on AI communications and external publications;
promote consistency in considerations related to AI when evaluating drug safety, effectiveness, and quality;
enable CDER to meet federal AI requirements and align with FDA and HHS AI goals; and
facilitate trustworthy use of AI in the Center’s regulatory, research, and administrative efforts.

Cavazzoni says the council will soon inventory all CDER AI projects, expand tracking of AI efforts in the Center, and establish a centralized process through which offices will be required to seek consultation and support for the deployment of future AI projects. It also will conduct a landscape assessment to better understand CDER staff’s knowledge of and application of AI in their daily work.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome