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A Texan MRI manufacturer has admitted in federal court to faking documents in a recent trade secret suit against a competitor that resulted in its being awarded $25 million. Read More
Legislation to allow the Centers for Medicaid & Medicare Services to make coverage decisions more quickly could be on deck before the end of the year, lawmakers suggested during ongoing hearings on the House Energy & Commerce Committee’s 21th Century Cures initiative. Read More
The FDA’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More
IBSA Farmaceutici did not open a corrective action, as required, for a trend in adverse events involving pain and/or swelling in the knee following injection of Sinovial or other sodium hyaluronate devices, according to a Form 483. Read More
Health Line International, a Chinese devicemaker, received an FDA Form 483 for delaying effectiveness checks on CAPAs and other quality issues. Read More