1. Pink Sheet
  2. >>Advanced Technologies
  3. >>AI

EMA, US FDA Worry About AI’s Pitfalls And Promises

 
• By Derrick Gingery

The “garbage in, garbage out” issue remains top of mind as AI models continue to be integrated into drug development. The FDA still has a lot of learning to do, Jacqueline Corrigan-Curay says.

AI and human hand
Could AI exacerbate clinical trial diversity concerns? • Source: Shutterstock

US and European officials have big plans for artificial intelligence, including use in application review and safety signal identification, but both regulators remain concerned about the software’s limitations.

AI could help sponsors identify potential new drug targets or analyze the increasing volume of drug safety reports received each...

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
Start Free Trial

Already a subscriber?

More from AI

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

 
• By Sue Sutter

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 Aakash Babu

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

 
• By Francesca Bruce

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.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

More from Advanced Technologies

Kris Joshi Named Norstella CEO, Prioritizes AI Innovation

 
• By Aakash Babu

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

 
• By Francesca Bruce

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.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 
• By Eliza Slawther

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.