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The FDA has classified three recalls as Class I because use of the devices carries the potential of serious adverse health effects and death. Read More
After evaluating reports of suicidal thoughts or action in patients taking diabetes and weight loss drugs containing glucagon-like peptide 1 receptor agonists (GLP-1 RA) such as Ozempic/Wegovy, Byetta, Trulicity and Rybelsus, the FDA says its preliminary evaluation has found no evidence of these adverse events. Read More
To address the ongoing U.S. shortages of Bicillin L-A, a drug used to treat syphilis, the FDA has temporarily approved French manufacturer Laboratoires Delbert to import 3.6 million units of Extencilline, (benzathine benzylpenicillin) a drug not approved by the FDA, but also used to treat syphilis. Read More
In two recently issued documents, the FDA tackled methods for requesting reconsideration of an ANDA decision and provided final guidance on evaluating the viral safety of biotechnology products. Read More
During a virtual town hall Wednesday, FDA staff divulged there are currently no fully adequate substitutes for ethylene oxide (EtO), a chemical used to sterilize half of all medical devices in the U.S., and which can also cause an increased risk of various cancers. Read More
In response to an FDA warning letter about its placental-derived tissue product Axiofill, MiMedx Group defended its position that Axiofill is not a biologic drug and therefore not subject to additional oversight. Read More
The FDA approved 55 novel drugs and five biosimilars last year — substantially more than the 36 approved in 2022, according to the agency’s year-end report, but similar to the numbers approved in prior years. Read More
Sen. Bernie Sanders (I-Vt.), chair of the Senate Committee on Health, Education, Labor and Pensions (HELP), along with Democrats on the committee, has launched an investigation into the high price of asthma inhalers in the U.S., targeting four makers of the devices — AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline (GSK) and Teva Pharmaceuticals. Read More
This edition of Quick Notes looks at recent FDA Class I and company recalls involving patient return electrodes, pump-incompatible syringes, unintentional double drug dosing and missing zeroes. Read More