There needs to be a cultural shift to foster trust between regulators and the medtech industry when developing real-world evidence (RWE) to support the marketing of medical devices, according to ...
The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter ...
Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
Practical case studies and regulatory insights with a special focus on the Belgian context. Join us for an engaging morning of practical case studies and regulatory insights with a special focus on ...
A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to ...
Top US Food and Drug Administration (FDA) medical device officials said they are focused on restaffing after last year’s reduction-in-force (RIF) and are optimistic about the Medical Device User Fee ...
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 ...
Major pharmaceutical companies are urging the US Food and Drug Administration (FDA) to adopt a more flexible, risk-based approach in its guidance on testing container-closure systems (CCS) for drugs ...
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 ...
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