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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The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling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
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