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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
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
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
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More
The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine headaches. Read More