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A coalition of drugmakers wants to boost performance at clinical trial sites by establishing common standards for good clinical practices and skill requirements for investigators. Read More
The FDA has issued a warning letter to Vention Medical’s Costa Rica facility for violations of environmental controls, equipment upkeep and other quality issues. Read More
The FDA is telling Health Science Products to get certification from an outside expert, after the company purchased components from unqualified suppliers. Read More
With 12 recalls in less than 36 months, Johnson & Johnson tops the list of the five medical devicemakers with the most Class I recalls between 2012 and the present, according to FDA data. Read More
Manufacturers of medical devices that contain nanomaterials should use a phased approach to evaluate risk to avoid unnecessary testing, an expert committee of the European Commission recommends. Read More
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More
Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said. Read More
As 3D printing gains popularity among medical devicemakers, the FDA wants to get advice from manufacturers and researchers to guide its product reviews and, possibly, future guidance. Read More