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Despite overall enthusiasm for the use of multi-cancer diagnostic (MCD) tests, several members of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee raised concerns about the social and emotional risks the technology might carry. Read More
At an FDA advisory committee convened to gather insights on multi-cancer diagnostic (MCD) tests, the 10-member advisory panel veered off course when the topic of endpoints arose, voicing varying levels of support for mortality endpoints in trial design. Read More
The FDA is proposing to classify for the first time certain wound dressings and liquid wound washes containing antimicrobials or other chemicals, an action that would also mean a premarket application (PMA) would be required for some of them. Read More
Vivos Therapeutics achieved a first in obtaining FDA clearance of its removable oral appliance for severe obstructive sleep apnea — an alternative to continuous positive airway pressure (CPAP) or surgical implants — while Philips Respironics deals with potential overheating issues in its DreamStation 2 CPAP devices. Read More
This edition of Quick Notes highlights recalls for Excela sodium bicarbonate, sodium chloride and cysteine hydrochloride, Novartis cyclosporin, Bayer larotrectinib, Unomedical VariSoft infusion sets and SoClean CPAP cleaner. Read More
The troubled U.S. drug supply chain remains in the spotlight with President Biden announcing nearly 30 new actions to help bolster supply chain resilience, including convening a new White House council focused on the issue and deploying the Defense Production Act to bolster U.S. manufacturers’ ability to make more essential medicines. Read More
The FDA has withdrawn from the Global Harmonization Working Party (GHWP) and will focus its efforts to ensure alignment of medical device international harmonization by primarily working with the International Medical Device Regulators Forum (IMDRF). Read More
The lot size doesn’t really matter when it comes to choosing a sample size for a pharmaceutical or medical device, says sampling expert Steven Walfish. Read More
Reorganization of two of the FDA’s larger offices in 2024 will bring about changes in how the agency handles inspections and drug assessments. Read More
When the rare disease patient community was seeking to have the FDA pay more focused attention to orphan drugs, they asked Janet Woodcock for support. She established within CDER a new office dedicated to orphan drugs and rare diseases. Read More