Artificial Intelligence: CDER’s New Council Takes Charge Of Oversight, Coordination

The Artificial Intelligence Council takes over work that three different entities in the US FDA’s drugs center had been performing. The new, centralized entity will develop and promote consistency in AI-related activities and advance innovative uses.

Chess piece
A new group is in charge of AI oversight and coordination at the FDA's drugs center. • Source: Shutterstock

The US FDA’s Center for Drug Evaluation and Research is consolidating oversight and coordination of all internal and external artificial intelligence efforts into one centralized entity.

Key Takeaways
  • CDER’s new Artificial Intelligence Council will coordinate and oversee all AI activities.

  • The single, centralized council will replace three different entities

The new Artificial Intelligence Council will coordinate, develop, support and promote consistency in AI-related activities throughout the drugs

More from AI

More from Advanced Technologies

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By 

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence

 

Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.