From The Scientist:
AI Will Accelerate the Regulatory Pipeline
The Food and Drug Administration (FDA) and the European Medicines Agency have been moving—thoughtfully but decisively—toward a more aligned, forward-looking set of rules that do more than protect the public: They create room for responsible progress. With the EU AI Act coming into effect in the first half of 2026 and the FDA beginning to deploy generative AI tools to support and accelerate regulatory review, there will be a new regulatory position: guidance that is faster, more data-driven, and anchored in transparency, explainability, an…
From The Scientist:
AI Will Accelerate the Regulatory Pipeline
The Food and Drug Administration (FDA) and the European Medicines Agency have been moving—thoughtfully but decisively—toward a more aligned, forward-looking set of rules that do more than protect the public: They create room for responsible progress. With the EU AI Act coming into effect in the first half of 2026 and the FDA beginning to deploy generative AI tools to support and accelerate regulatory review, there will be a new regulatory position: guidance that is faster, more data-driven, and anchored in transparency, explainability, and continuous performance monitoring.
Regulators appear to be increasingly prepared to let AI handle routine, low-risk research tasks with minimal friction, while keeping firm human control over decisions that directly shape safety, ethics, and public trust. That is the right hierarchy. If they stay on this course, international coordination and iterative learning between agencies will not just keep up with AI, they will shape it. The result is substantial: more efficient drug development, lower costs, and more timely, representative access to better therapies. The challenge, which we cannot underestimate, is to ensure that the governance, safeguards, and ethical commitments evolve as quickly as the technology they aim to oversee.
More here.
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