We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Devicemakers whose products include a drug component could find GMP compliance especially tricky, due to a 2013 regulation that requires expiration dates like those used for drugs, an industry expert says. Read More
Indian regulators are establishing quality manufacturing standards for medical devices and diagnostics to align the country’s requirements with international standards and move away from its system of regulating the products under rules designed for drugmakers. Read More
Hospira is recalling all of its GemStar Power Supply 3VDC units, used to power the GemStar Infusion Pump, because they may fail to deliver electric power to the pump. Read More
A new Society for Clinical Research Sites white paper outlines a set of best practices that members of industry group TransCelerate hope will eventually help clinical trial sites improve their compliance. Read More
Clinical trial sites need to brush up on their good clinical practice training specs and shouldn’t expect sponsors to compensate them for doing so, says Christine Pierre, president of the Society for Clinical Research Sites. 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