In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.
US Food and Drug Administration Commissioner Martin Makary is considering combining all of the agency’s adverse event reporting systems into...
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There is still no clarity on how life sciences will be treated in the final agreement.
NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.
The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.
In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
Medicare beneficiaries with tricuspid regurgitation will now have access to an innovative treatment from Abbott that offers a minimally invasive alternative to open-heart surgery.
Research recently published in JAMA Internal Medicine found that the FDA met its review timeline goals for the majority of breakthrough devices – but also revealed some apparent shortcomings in safety data supporting the submissions.
