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The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of AI/machine learning (ML) and increased collaboration between the agency and industry. Read More
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
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
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
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