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Within the supply chain universe, medical technology and its countless components needs to stay front and center when competing with other industries, emphasized the FDA’s lead officer on the subject during a two-day workshop on generic drug-device combination products last week. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws and regulations that could impact your business. Read More
Four units within the FDA have worked together to publish a paper to provide greater transparency on how they will collaborate with the pharmaceutical industry as it develops and deploys AI technologies. Read More
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