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CDRH, as part of its MDUFA V commitments, has released a draft plan to further its work toward globally harmonized medical device regulation, policy and practices as part of the effort to reduce redundant expectations and requirements among international regulatory bodies. Read More
Upcoming events in the coming weeks include seven 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 calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect from the FDA in 2024. Read More
Applications that use AI and machine learning (ML) have a unique dependence on data, said the FDA’s Digital Health Center of Excellence Acting Deputy Director MiRa Jacobs at Tuesday’s open forum held by the Alliance for a Stronger FDA. Read More
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how, or if, the corresponding software function should be described in the prescribing information (PI). Read More
The best way to design trials around an artificial womb intended to better regulate body temperature and foster safer lung development in extremely premature infants (EPI) is the focus of the FDA’s Pediatric Advisory Committee (PAC) as they meet on Tuesday and Wednesday of this week. 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
Over the past week, the FDA issued final guidance on IRB review of individual patient expanded access submissions, postmarketing requirements and commitments, the Breakthrough Devices Program and the medical device Voluntary Improvement Program. Draft guidances were also issued on clinical and non-clinical studies of weight loss medical devices. Read More
The association said that they have seen lawyer-funded and investor-backed advertising mislead patients into seeking legal action for non-faulty devices. Read More
On Thursday, the FTC voted unanimously (3-0) to issue a policy statement warning pharmaceutical companies that they could face legal action for improperly listing patents in the FDA’s Orange Book in an attempt to stave off competition. Read More