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…
Over the past week, the FDA issued a final guidance viral safety evaluation of biotechnology product derived from human or animal cells and draft guidance on sterility information in 510(k)…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid out the final roadmap for 2024 to create a comprehensive set of regulations for medical devices and technology, bringing…
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…
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. Source: Drug…
FDA Commissioner Robert Califf wants to push the agency toward approving AI assisted medical devices that contain algorithms capable of learning, adapting and changing as they gather and analyze 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…
There’s been a rising concern with clinical trial fraud and misconduct, particularly over the number of “zombie” trials that have been discovered in recent years — that is, trials in…
BD has announced a settlement in the class action lawsuit related to its Alaris infusion pumps, agreeing to pay $85 million to resolve all the claims against the company and…
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…