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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
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
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