The nation’s largest pharmacy benefit managers (PBM) have drastically consolidated to a select and much-enriched few while wielding “enormous power and influence” over American consumers, the FTC illustrated in a…
To aid drug and device makers in battling misinformation about their products, the FDA has issued a 21-page question-and-answer draft guidance that provides firms with ways to address the issue.…
This edition of Quick Notes looks at FDA approvals and clearances for devices involving digital pathology images, implantable device protective pockets, and measurement/monitoring systems for obstetrical and cardiac care. Source:…
The potential for radiofrequency coils heating up during an MRI scan has led the FDA to deem Philips’ recall of its Sense XL Torso Coils as Class I, as overheating…
To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA),…
Multiple and repeated violations found in Sun Pharmaceuticals’ Dadra, India facility during a December 2023 FDA inspection have resulted in a Warning Letter following the company’s inadequate responses to a…
CBER has published an updated list of guidance topics for development during 2024. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws…
The new definition of Alzheimer’s as any abnormal level of amyloid beta or tau — even in the absence of symptoms — could vastly expand the market for treating the…
The FDA is proposing to adopt a new guideline from the International Council for Harmonisation (ICH) on the use of real-world data (RWD) in pharmacoepidemiological studies of drug, vaccine and…