We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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the FDA issued a final guidance viral safety evaluation of biotechnology product derived from human or animal cells and draft guidance on sterility information in 510(k) premarket notifications and requests for reconsideration of division level under GDUFA. Read More
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 the UK one step closer to finalizing its regulatory framework after leaving the EU. 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
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 data — which is not the technology in the AI-assisted devices FDA has approved thus far. 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
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 which a portion of the data is either invented out of whole cloth or is manipulated to the point of dishonesty. Read More
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 it officers. 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