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The proposed regulation to curb ethylene oxide (EtO) emissions would bring some surgeries and other medical procedures to a screeching halt, a medical device industry representative told a congressional subcommittee on Wednesday. Read More
The FDA has issued a draft guidance intended to strike a balance between health care providers’ interest in scientific information on unapproved uses of approved/cleared medical products and mitigating the FDA’s interest in prohibiting use of a product for an unapproved indication. Read More
In this edition of Quick Notes, we cover another Philips ventilator recall, GE HealthCare and Novo Nordisk collaborate to develop a diabetes and obesity ultrasound treatment and 510(k) clearance for Insulet’s Omnipod 5 App for iPhone. 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
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