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A proposed regulation issued by the FDA today would amend current Good Manufacturing Practice (cGMP) rules for combination products containing medical gases, focusing on requirements for standardized labeling and manufacturing procedures specifically for drug-device combinations. Read More
In a recently promised update on medical device reports (MDR) associated with suspected foam breakdown in certain Philips Respironics devices, the FDA reports it received more than 21,000 MDRs, including 124 reports of deaths, from April 2021 through April 2022. Some of the injuries noted by the FDA include cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, difficulty breathing, dizziness, nodules and chest pain. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require sponsors to file an in-depth recruitment strategy, either before or with their investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require sponsors to file an in-depth recruitment strategy, either before or with their investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
Medtronic released interim results showing that its Evolut transcatheter aortic valve replacement (TAVR) system resulted in a low level of complications and death when implanted using a specific technique. Read More
Abbott reported study findings for its TriClip tricuspid heart valve repair device at the annual European Association of Percutaneous Cardiovascular Interventions (EuroPCR) meeting being held this week in Paris, France. Read More
Pharmaceutical manufacturers are playing something of a shell game with inhalers, maintaining their patents and market exclusivity with new products that aren’t really new, according to research reported in the journal Health Affairs. Read More