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 ...
The European Medicines Agency (EMA) is holding a consultation into the methodological aspects of confirmatory platform ...
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 ...
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 ...
The US Food and Drug Administration (FDA) on Tuesday finalized guidance to address how sponsors can develop, distribute, and ...
Despite some early jitters, the medtech industry is coming around to the Quality Management System Regulation (QMSR), ...
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published “review points” for medical devices using generative AI. The document, an English-language translation of a Japanese PMDA text ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results