In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Source: Drug Industry…

The FDA is increasingly finding cybersecurity lapses during inspections of medical device manufacturing facilities — and most often because cybersecurity risk management is not fully documented as part of design…

The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Source: Drug Industry…

To regulate new medical device technologies, the FDA should rely on familiar regulatory processes to review low-risk activities while adopting a more attentive approach that devotes greater resources to high-risk…

The FDA is seeking input on a new draft guidance intended to help manufacturers develop strategies for ensuring potency in human cellular or gene therapies (CGT). Source: Drug Industry Daily

BioTelemetry, owned by Philips, and its subsidiary LifeWatch Services have agreed to pay more than $14.7 million to resolve allegations that they violated the False Claims Act by knowingly submitting…

Over the past week, the FDA issued a final rule on direct-to-consumer prescription drug advertisements. The agency issued final guidance on development of drugs and biological products for rare diseases,…

The FDA will kick off the new year under another possible threat of a shutdown because lawmakers have so far failed to agree on fiscal 2024 funding for the federal…

Acclarent, a division of Johnson & Johnson, has received FDA clearance for use of its AERA eustachian tube balloon dilation system in the treatment of children age 8-17 with persistent…

A five-year-old agreement between the FDA and the Cybersecurity and Infrastructure Security Agency (CISA) on medical device cybersecurity should be updated to reflect new practices, according to a recent report…