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.
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
Rather than try to explain the models, they would constrain them with careful training and guardrails – and by
The FDA plans to implement generative AI for drug reviews by 30 June 2025, enhancing efficiency and potentially accelerating approval processes. Discussions with OpenAI about AI integration are ongoing.
An interactive look at pharma, medtech and diagnostics deals made during April 2025. Data courtesy of Biomedtracker.
Plans have been submitted for a £1bn development in London that can home biotech companies and encourages cross collaboration with the Institute of Cancer Research. In Vivo took an exclusive tour of the UK’s prospective new cancer innovation district.
