FDA drafts AI-enabled medical device life cycle plan guidance
The Meals and Drug Administration declared the availability of draft guidance that presents suggestions on life cycle controls in submissions to industry device studying-enabled product application capabilities. WHY IT Matters In the document, “Marketing Submission Suggestions for a Predetermined Modify Control…
New FDA electronic records guidance prioritizes Digital Health Technology oversight | Hogan Lovells
Importantly, this revised draft guidance is a very clear illustration that Fda is more and more centered on the integrity of electronic facts generated in medical trials. As just one unique example of this, the draft direction emphasizes the want…
Biden administration gutting online education with new ‘harmful’ guidance, warn experts, lawmakers
The Biden administration will now be able to crack down on private companies that contract with colleges and universities to help the schools run their online education programs, raising alarm bells among experts and lawmakers who warned the federal government…
Holiday Rush Brings Health Plans Eagerly Awaited RxDC Reporting Guidance and Relief | Faegre Drinker Biddle & Reath LLP
In FAQs Component 56, issued on December 23, 2022, the Treasury Department and the Departments of Labor and Wellbeing and Human Products and services (collectively, Departments) issued important steering on prescription drug advantage and expense reporting expected of well being…
Healthcare Workers Unhappy With New CDC Mask Guidance
Hospitals and healthcare employees are not delighted with current CDC recommendations to fall universal masking in healthcare options. Late very last 7 days, the agency quietly posted new direction that scrapped common masking for health care staff. Now, hospitals and…
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