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An FDA advisory panel has voted 11-2 against approval of SOLVD Health’s De Novo request to market AvertD, a genotype test to identify patients at increased risk of opioid use disorder (OUD). Read More
The FDA’s biggest challenge in protecting medical devices from cybersecurity breaches is legacy technology, says a top agency technology official. Read More
The FDA handed Akron Coating & Adhesives a Form 483 for not properly testing or controlling combination drug-device products at its Akron, Ohio, facility. Read More