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.
Medical device companies and big pharma need to be more proactive in terms of utilizing social media. That’s according to one expert who spoke at a recent FDAnews webinar. Read More
Ensuring that agency staff is adequately trained, promoting the use of best scientific practices and improving communications with the public are three of the goals the new head of Brazil’s healthcare regulator is promising to tackle during his tenure. Read More
How can U.S. healthcare regulators encourage stakeholders to adopt standards related to the reporting of laboratory data? That question will be the focus of a fall workshop led by the FDA, Centers for Disease Control and Prevention and the National Library of Medicine. Read More
To reduce dosing errors that have resulted in deaths and patient adverse events, the FDA is providing manufacturers with labeling and safety testing recommendations for medical devices and combination products containing the blood thinner heparin. Read More
The European Medicines Agency is seeking information on an implant sold by a Medtronic unit after inspectors determined that a U.S.-based supplier of an active substance for the product had deviated from good manufacturing practices. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is advising companies that remanufacture single-use medical devices that they are subject to the same adverse event reporting requirements as original equipment manufacturers. Read More
To reduce possible burn injuries, the FDA is recommending that manufacturers of magnetic resonance-conditional devices assess radiofrequency-induced heating in MR environments. Read More
The FDA is clarifying language related to the direct marking of medical devices for unique device identification purposes, including the definition of reprocessing. Read More
Devicemakers looking to get new products on the market should prepare to shell out more money in fiscal year 2016, as user fees for all types of applications are rising. Read More