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Our coverage spans an Adcomm decision on use of phenylephrine, 1Health.io FTC order for failure to protect privacy and security, user fees for OTC monograph order requests and a GDUFA report available. Read More
Royal Philips, Amsterdam-based parent company of Philips Respironics, reports that it’s close to settling multiple lawsuits related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. Estimated amount: $616 million. Read More
Our coverage spans an Abbott acquisition, FDA draft guidances on endogenous Cushing’s syndrome and peptide drug development, EMA guideline revision on clinical trials for depression treatments and a GAO report on drug rebates in Medicare part D. Read More
Medtronic MiniMed has been accused of transmission and disclosure of HIPAA protected personally identifiable information (PII) and protected health information (PHI) from its InPen diabetes management system to Google, Crashlytics and other tracking tools. Read More
New resources are needed to support CMS’s Coverage and Analysis Group’s coverage decisions for FDA-approved breakthrough medical devices, says a new report from AdvaMed and Health Management Associates, to decrease the review time for medical devices. Read More
More than 20 billion devices are sterilized with EtO each year, CDRH says, representing about 50 percent of devices that require sterilization. Read More
CDRH has recognized low temperature vaporized hydrogen peroxide as an alternative to ethylene oxide (EtO) for medical device sterilization and is updating its reference documentation to assist manufacturers in making changes to sterilization procedures. Read More
The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Read More