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The FDA “remains unsatisfied” with Philips Respironics’ handling of the recall of its 15 million ventilators, bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines. Read More
This year, those making combination products find themselves in a swirl of potentially confusing regulations and standards regarding risk management. Read More
Seeking to address the growing problem of how misinformation undermines confidence in both science and the FDA, the Regan-Udall Foundation has released a report focusing on how the FDA can deliver clear messaging to deliver improved understanding of the FDA and the products it regulates. Read More
Over the past week, the FDA issued a proposed rule on laboratory developed tests, final guidance on labeling for dosing of human prescription drugs and biological products and draft guidance on stimulant drug use disorders. Read More
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