1. In Vivo
  2. >>Innovation

Explaining The Unexplainable: How To Win US FDA’s Trust In Artificially Intelligent Drug Manufacturing

 
• By Bowman Cox

One issue that has surfaced as the pharmaceutical industry responds to the US FDA’s recent discussion paper on manufacturing with AI machine learning models is the question of how to explain what the models are doing.

Artificial and human intelligence
the decisions are obvious even when the explanations are not • Source: Shutterstock

The question of how to explain what artificial intelligence models are doing is emerging as a key regulatory issue in pharmaceutical manufacturing.

The “explainability” of self-learning AI models can be so low, many would sidestep the challenge by treating them more like people than machines.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo 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 Innovation

Finding The Fire: AltruBio’s Novel Approach To Autoimmune Disease

 
• By David Wild

CEO Judy Chou brings big pharma experience to tackle chronic inflammation with the company's first-in-class PSGL-1 targeting therapy.

Late-Stage GLP-1 Drug Trials Outside The Cardiometabolic Space

 
• By David Wild

A look at Novo Nordisk, Eli Lilly and other companies' late-stage clinical studies of GLP-1 drugs in indications ranging from neurodegeneration to oncology, and alcoholic liver disease to autoimmune conditions.

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By Ashley Yeo

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

More from In Vivo

AI In Health Delivery: Patients Most Confident When HCPs Are In Charge

 
• By Ashley Yeo

Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.

Rising Leaders 2025: Metsera’s Whit Bernard’s Musical Path To Biotech Leadership

 
• By David Wild

Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.