Fierce Biotech August 29, 2024
The FDA’s Center for Drug Evaluation and Research (CDER) is consolidating its artificial-intelligence-related activities under a single AI Council, in part in response to efforts from the Biden administration to ensure the safety and security of machine learning software.
In an email to agency staff, CDER Director Patrizia Cavazzoni, M.D., said the new council would replace the center’s separate AI-related steering committee and policy working groups and would continue its work within the federal government-wide AI Community of Practice.
Its remit will also include overseeing how AI is used within pharmaceutical R&D and applications from drugmakers as well as how AI programs may be tapped internally by the agency’s product reviewers and other administrative employees.
“While multiple CDER groups have...
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