Article Summary:
This week, US lawmakers are working to pass a “minibus” budget bill to fund the FDA and other agencies, despite the ongoing government shutdown. During the shutdown, the Department of Health and Human Services (HHS) accidentally sent reduction-in-force notices to twice as many employees as intended due to data and processing errors.
The text also covers several regulatory updates from the FDA. The Center for Biologics Evaluation and Research (CBER) published a policy on finding lists of disqualified or restricted clinical investigators, and approved the use of convalescent plasma from COVID-19 recovered patients as a treatment. The FDA also issued a final guidance on handling data sets for acute leukemia drug approvals, and published a Form 483 inspection report for Hetero Labs’ active pharmaceutical ingredient facility.
In medical device news, the FDA issued a safety communication regarding radiofrequency microneedling devices, warning of potential burns, scarring, and other injuries. Additionally, the FDA cleared Roche’s Elecsys pTau181 test, the first blood-based biomarker test to help with initial Alzheimer’s disease diagnosis in primary care settings.
The text also mentions a survey by the Kaiser Family Foundation and Washington Post, which found that 40% of American parents support the “Make America Healthy Again” movement led by HHS Secretary Robert Kennedy Jr., though only half of those supporters trust him on vaccine information.