AI Assurance Lab Concept Leaves Potential Regulatory Gap

 
• By Derrick Gingery
  
Generate a summary of this article
Listen to this article
Beta

In an interview with the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

AI in drug development
The FDA is investing in AI lifecycle management, Tazbaz said. • Source: Shutterstock

Assurance labs, a potentially key part of the development of artificial intelligence for pharmaceutical use, are not part of the official regulatory process yet, which could raise questions for the US Food and Drug Administration as the technology pushes further into the industry.

Key Takeaways

  • The FDA’s AI regulatory process currently cannot oversee assurance labs that would help test the algorithms to ensure they are working as intended.

AI models in development for medical product research and clinical practice are expected to need oversight before and after deployment...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from AI

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

 
• By Sue Sutter

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

Use AI In Health Technology Assessments Only When Valuable, England’s NICE Tells Pharma Firms

 
• By Eliza Slawther

Pharmaceutical companies should only use AI in evidence generation and reporting where there is “demonstrable value from doing so,” according to England’s health technology assessment body, NICE.

$14m Handout Anyone? Shanghai Offers Raft Of New Biopharma Incentives

 
• By Brian Yang

Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.

Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

 
• By Vibha Ravi

From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.

More from Advanced Technologies

CAR-T Therapies: Rethinking Of Postmarketing Requirements And REMS Urged

 
• By Sue Sutter

Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.

test

 
• By Sabbah and Saba Afreen

test

Gene Therapies: CoGenT Pilot Could Help With Regulatory Convergence Earlier In Development TEST

 
• By Sue Sutter

Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.