The US Food and Drug Administration (FDA) recently issued warning letters to drugmakers in Japan and the US, as well as a ...
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The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review ...
A panel of experts at RAPS Euro Convergence 2026 discussed how artificial intelligence (AI) is being applied throughout the ...
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) draft guidance on new approach ...
A Health Technology Assessment Regulation (HTAR) governance body has published guiding principles on data transparency.
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
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