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Over the past week, the FDA issued final guidances on testing for methanol in alcohol, premarket notification for magnetic resonance diagnostic devices, patient remote monitoring devices, benefit-risk assessments for new drug and biological products and voluntary consensus standards for regenerative medicine therapies. Draft guidance was issued on treatments for diabetic foot infections. Read More
In this edition of Quick Notes, we cover a pharmaceutical ingredient cartel, fake Ozempic pens and new transparency rules for the European Medicines Agency clinical trial information system. Read More
The FDA has deemed Hamilton Medical’s recall of certain of its ventilators as class I, the most serious type of recall, as a potential leak could cause the machine to stop delivering air, which could lead to serious injury or death. Read More
Taking effect immediately is a guidance on non-invasive remote monitoring devices that gather patient physiological data from afar, reducing the need for in-office or in-hospital services. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024, quality culture and how to use UDI and UDI Data. Read More
Though it might seem counterintuitive given the complex regulations and procedures required of the drug and device development industries, the real key to better quality lies in simplifying operations, said Greg Williams, industry veteran and a quality assurance consultant based in Dallas-Ft. Worth. Read More
Illumina has already begun preparing for the divestment of Grail, although the company has already filed a challenge against the order with the European Court of Justice, claiming that the European Council (EC) does not have jurisdiction over the acquisition. Read More