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The issues the industry is grappling with these days dovetail perfectly with topics on tap at the GMP Quality Management Virtual Summit 2023 Oct. 11 and 12, according to Steve Lynn, this year’s new conference lead. Read More
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024 and how to use UDI and UDI Data. Read More
In a final guidance published by CBER and CDRH, the FDA provides updated standards for premarket notification (510(k)) submissions by electronic format and establishes Oct. 1 as the start date for use of the revised standard. Read More
A recent study of cardiac patients using a digital health solution found no long term impact on physical activity, demonstrating the difficulty of establishing the value of digital health technology. Read More
Invitae’s in vitro diagnostic test that uses a blood sample to help detect hundreds of genetic variants associated with an elevated risk of developing certain cancers has received de novo marketing authorization by the FDA. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Report alleges the company did not begin a formal investigation until 2019, nine years after the first complaints and three years after company tests showed problems. Read More
Citing a continued dramatic growth in the use of laboratory-developed tests (LDT) over the past two decades, the FDA Friday announced a proposed rule that would bring the tests under the agency’s purview, trying a new route to put to rest the decades-long debate over who should provide oversight. Read More
A government shut down as of midnight on Saturday — the end of the fiscal year — appears likely as partisan disagreements about federal discretionary spending rage on with no clear end in sight. Read More