Percussionaire’s recall of High-Frequency Transport Phasitron Breathing Circuit kits has been identified as a Class I recall by FDA due to a product defect that causes over-pressurization. Source: Drug Industry…
The FDA did not attend a House Energy and Commerce subcommittee hearing Tuesday focused on why the agency has stalled out on its pre-pandemic efforts to improve inspections of overseas…
An analysis of 10 FDA approved drug-device combinations containing GLP-1 receptor agonists found that the patents for the device portion made no mention of active drug ingredients — a requirement…
The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s…
Philips North America’s recall of its Brightview gamma camera system, used in nuclear medicine, has been deemed Class I by the FDA, for the potential of the camera falling on…
Listen to FDA Drug Safety Podcast titled, FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). Source:…
By overriding the FDA’s scientific judgments and methodology, the Fifth Circuit second-guessed the FDA’s Congressional mandate to consider all scientific evidence in drug approval decisions, the American Bar Association (ABA)…
A bipartisan group of six senators have released proposed reforms to the beleaguered 340B drug discount program that they claim will ensure the program fulfills its original purpose of supporting…
Evaluating the accuracy of pulse oximeter readings on individuals with differing skin pigmentation, and differentiating between the device’s medical vs. OTC versions dominated the discussions during Friday’s FDA advisory committee…
During the second session of the 118th Congress, FDAnews will track pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations…