FDA Revises Recent Recall InformationBiomedical Safety & Standards
FDA Headquarters Regulatory & Quality FDA Wrapped: Prominent Guidance From 2024 A look at the most notable guidance that emerged from CDRH this year. byHeather R. Johnson Sign up for the QMED & MD+DI Daily newsletter. SUBSCRIBE TODAY
FDA is working with Boston Sci to evaluate whether all Accolade pacemakers have the risk of permanently entering safety mode, thus meaning they would need to be removed. byKatie Hobbins, Managing Editor Sign up for the QMED & MD+DI Daily newsletter. ...
In June 2023, the FDA updated industry guidelines that apple juice cannot contain inorganic arsenic at levels more than 10 parts per billion (ppb). The Refresco apple juice recall was initially issued because the juices were found to have arsenic levels of 13.2 parts per billion, FOX Business...
In recent years, the U.S. Food and Drug Administration (FDA) has seen an increase in microfluidic medical device submissions, likely stemming from recent advancements in microfluidic technologies. This recent trend has only been enhanced during the COVID
In 2009, the US Food and Drug Administration (FDA) agreed to use HE4 to diagnose and monitor OC [35]. Later in 2011, it also approved its use in combination with the marker CA125 as a part of the Risk of Ovarian Malignancy Algorithm (ROMA) for the OC diagnosis, especially in the ...
Many ready-to-eat meals have been recalled due to chicken and even burger. Product Recalls FDA Recall Update for October 2024 byKristen Kazarian Plants & Facilities Schenck Process FPM is Officially Coperion Cosmetics & Personal Care Skin Sunscreen Foundation Recalled for Microbial Contamination ...
A certain class of drugs used to treat Type II diabetes, which falls into the class of SGLT2 inhibitors, has raised questions about whether the risks of side effects are truly worth the benefits this drug is supposed to provide. The FDA has been continuously reviewing thes...
“I would be open to a drug that enhances my cognitive ability, but I would want something with minimal side effects.” “I’m open to medication […], as long as it was specifically targeted and individualised for me.” “Targeting concentration would be a really good first step, because...
Reported positive topline results from the HELIOS-A Phase 3 study in hATTR amyloidosis patients with polyneuropathy, with plans to file a New Drug Application (NDA) with the FDA in early 2021. Continued enrollment in the HELIOS-B Phase 3 study i...