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This month a dextromethorphan-based medicine flunked out for AD agitation, but agents for schizophrenia, mantle cell lymphoma and a clotting disorder did well, with some ready to make the regulatory leap. Read More
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 Board to the National Center for Toxicological Research. Draft guidance was published on the platform technology designation program for drug development. Read More
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 items previously refused admission. Read More
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) as medical devices claiming that the FDA doesn’t have the authority to scrutinize LDTs. Read More
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 used the company’s products. Read More
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. Read More
This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
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 Securities and Exchange Commission (SEC). Read More
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). Read More
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 draft of a guideline on general principles for planning pharmacoepidemiological studies is ready for review. Read More
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. Read More
An FDA advisory committee voted 7-4 that the risk of serious hypoglycemia seen with Novo Nordisk’s Awiqli insulin outweighed the convenience of its once-a-week dosing regimen for people with type 1 diabetes. Read More