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Rather than trying to predict which medical devices could be in short supply during a national emergency, the FDA should focus on identifying those that are “mission critical” to patient care, according to an agency advisory committee. Read More
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. Read More
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 manufacturers that supply drugs to the U.S. Read More
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 of FDA Orange Book listing. Read More
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 visibility into drug supply chains. Read More
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 the patient. Read More
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) wrote in its recent amicus brief on the Supreme Court’s upcoming review of the abortion drug mifepristone. Read More
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 covered entities helping underserved populations. Read More
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 meeting. Read More
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 that could impact your business. Read More
Novo Nordisk has agreed to acquire three fill-finish sites in connection with a transaction where Novo Holdings has agreed to acquire Catalent, a contract development and manufacturing company headquartered in New Jersey. Read More
The Biden administration has sent initial offers to manufacturers of the first 10 drugs selected for drug price negotiation, saying this is the first time Medicare is not accepting the drug prices pharmaceutical companies set. Read More