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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
This special edition of Quick Notes covers FDA issuance of final guidance for the Breakthrough Device Program, drug postmarketing requirements and commitments and the CDRH voluntary improvement program as well as draft guidances on clinical study design and non-clinical testing of weight loss devices. Read More
Our coverage spans relief from third party funded mass tort litigation sought by the medical device industry to Apple prevailing in Masimo patent appeal and two class I device recalls. Read More
Upcoming events in the coming weeks include eight 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
Our coverage spans an Adcomm decision on use of phenylephrine, 1Health.io FTC order for failure to protect privacy and security, user fees for OTC monograph order requests and a GDUFA report available. Read More