This week, the FDA issued a final rules related to the administrative destruction of medical devices that are thought to be counterfeit and announcing the termination of the Science Advisory…

The FDA has finalized a rule allowing it to destroy illegal medical devices valued under $2,500 that have been refused admission into the US as a deterrence against sellers re-shipping…

A clinical laboratory trade association and one of its member companies have filed suit against the FDA, asking the agency to overturn its final rule to regulate lab-developed tests (LDT)…

Spinal devicemaker Innovasis and its two senior executives, Brent and Garth Felix, have agreed to settle an anti-kickback whistleblower suit for $12 million for allegedly paying kickbacks to physicians who…

Philips Respironics has recalled several of its BiPap machines after 888 complaints of a potential malfunction of the device’s inoperative alarm which can cause the ventilator to shut down. Source:…

This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Source: Drug Industry Daily

A February data breach at drug distributor Cencora has exposed the personal medical information of tens of thousands of patients, according to filings with numerous state attorneys general (AG) and…

The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).…

The final version of an International Council of Harmonisation (ICH) guideline that addresses evaluation of the drug-drug interaction (DDI) potential of an investigational drug is ready for adoption and a…

This edition of Quick Notes looks at the FDA clearances for heart monitoring and lung disease diagnostic algorithms, an artificial pancreas app and a bipolar radiofrequency hysteroscopy system. Source: Drug…