Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Foc ...
Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug ...
FDA looks for evidence behind the corrective action Many companies recalled product, opened corrective and preventive actions (CAPAs), revised procedures, submitted records, or wrote to FDA more than ...
The US Department of Health and Human Services on Wednesday announced a program and funding opportunity through the Advanced Research Projects Agency for Health (ARPA-H) called the ...
A panel of regulators convened at the 2026 RAPS Convergence to discuss several initiatives underway in Europe to help ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is ...
Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of ...
Euro Roundup: EMA officials argue against making single pivotal trials the ‘rigid, default position’
Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a ...
The US Food and Drug Administration (FDA) has issued notices inviting subject-matter experts and consumer representatives to volunteer for its advisory committees. The move comes after the role of FDA ...
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