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.
Among devices subject to an FDA Class I recall from 2018-2022, only one-quarter of recall notices included adequate information to accurately identify the device or component at fault, according to a new study. Read More
The EU Commission’s latest guidance on its new medical device regulations provides a detailed explanation of the required content, as well as the structure, for the summary of a report on the results of a clinical investigation. Read More
Netherlands-based devicemaker Philips has agreed to pay $62 million to settle charges made by the U.S. Securities and Exchange Commission (SEC) that it “engaged in improper conduct to influence foreign officials ... to increase the likelihood that Philips’ products were selected” as well as using improper bidding practices in China between 2014 and 2019. Read More
The FDA is seeking feedback on a discussion paper focused on using AI and machine learning (ML) in drug development as well as in the development of medical devices intended to be used with drugs. Read More
Over the past week, the FDA issued several documents, including a final guidance for testing drug components for diethylene glycol and ethylene glycol and the announcement of a discussion paper on AI. Read More
An FDA advisory committee voted in favor of ARS Pharmaceuticals’ neffy (ARS-1), an intranasal epinephrine spray, as an alternate to epinephrine injection for severe anaphylactic allergic reactions despite the absence of clinical data. Read More