A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the ...
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LISBON – Industry representatives, patients, and regulators shared their perspectives on the reforms to the EU pharmaceutical legislation at RAPS Euro Convergence 2026. The panelists noted that many ...
The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving ...
The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices. The ...
Left to right: Frank Pétavy, Silvy Da Rocha Dias, Ivica Malnar, Sabine Haubenreisser, Alberto Gañan Jimenez, Marta Marcelino, and Kaisa Immonen. (credit: Ferdous Al-Faruque) LISBON – A panel of ...
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...
The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
Orphan medical device makers should be deliberate in their questions to expert panels and ensure their post-market clinical ...
A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the ...
Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to ...
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