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Researchers from the European Medicines Agency (EMA) have published a paper on regulatory research priorities for AI across the medicine lifecycle.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The European Commission has adopted a roadmap to phase out the use of animals in chemical safety assessments, including for pharmaceuticals.

Draft guidelines from the European Commission aim to assist companies in determining whether their products, including medical devices that incorporate artificial intelligence (AI) components, are classified as high-risk under the EU's Artificial Intelligence Act.

The US Food and Drug Administration (FDA) is more likely to approve drugs with an orphan designation that were indicated for subgroups of cancer or pediatric indications than the European Medicines Agency (EMA), the results of a recent cross-sectional study suggest.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.