US FDA And AI: Who Is In Charge?

The FDA is developing several structures and a broad group of experts across disciplines to help craft artificial intelligence policy. But the proliferation of AI-related initiatives raises the question of who, ultimately, will make decisions about when novel applications of AI are acceptable.

artificial intelligence
The growing number of AI experts at the FDA could lead to policy consistency questions. • Source: Shutterstock

When it comes to developing artificial intelligence policy, the US Food and Drug Administration has a broad base of staff expertise to use.

Key Takeaways
  • The FDA has a wide variety of AI expertise to help develop policy.

That fact was evident during a recent FDA/Clinical Trials Transformation Initiative meeting on AI in drug and biological product development....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from AI

Beijing City Releases AI Action Plan Including Drug Regulation

 
• By 

Amid the wait for an action plan to apply AI tools to drug regulation at the national level in China, capital city Beijing has released its own vision of scenarios for the technology in the healthcare sector.

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

 
• By 

Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By 

Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

More from Advanced Technologies

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By 

Joshi joins the parent company of Citeline, home of the Pink Sheet, to focus on AI, business harmonization and long-term growth.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.