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Over the past week, the FDA issued final guidance on assessing COVID-19 symptoms in adult and adolescent clinical trial subjects. Draft guidances were issued covering drug development for early onset Alzheimer’s disease, labeling changes for nonprescription drug NDAs and ANDAs, updates for the premarket cybersecurity guidance, E2D(R1) postapproval safety data, thermal effects of tissue heating and/or cooling medical devices and the Q-Submission program. Read More
Two weeks past its deadline, the Environmental Protection Agency (EPA) announced its final amendments to the air toxics standards for ethylene oxide (EtO) commercial sterilization facilities, calling the additions “the strongest measures in U.S. history to reduce emissions of EtO, one of the most potent cancer-causing chemicals.” Read More
The FDA’s legislative wish list for FY 2025 includes proposals to protect drug supply resiliency, amend the Hatch-Waxman Act, and exercise greater control over recalls. Read More
The FDA’s latest two draft guidances on medical devices address the ways in which submitters can request interactions with the agency and evaluating the thermal effects of devices that heat or cool tissue. Read More
Late Monday afternoon, the FDA announced its $7.2 billion budget request as part of President Biden’s $7.3 trillion fiscal 2025 proposed budget, which was released Monday. Read More
Manufacturers of cyber devices must have a plan to keep those devices secure for the product’s entire lifecycle, and sponsors of nonprescription drugs can include some minor labeling changes on an annual report, according to two new draft guidances issued by the FDA. Read More
A ventricular pumping system for heart failure patients could unexpectedly stop and start, prompting a correction recall from the manufacturer and a Class 1 recall announcement from the FDA. Read More
The recent glut of AI-fueled dermatology apps claiming to help consumers diagnose, track or treat skin conditions actually lack supporting evidence and don’t offer input from clinicians or dermatologists, according to a study published in JAMA Dermatology. Read More