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An FDA advisory committee voted in favor of ARS Pharmaceuticals’ neffy (ARS-1), an intranasal epinephrine spray, as an alternate to epinephrine injection for severe anaphylactic allergic reactions despite the absence of clinical data. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from medical device enforcement, real-world evidence and root cause analysis. Read More
Device manufacturers that apply a more risk-based framework to corrective and preventive action (CAPA) plans rather than using the more typical one-size-fits-all approach could see reduction of up to 80 percent in the time required to implement improvements. Read More
The Veteran’s Health Administration (VHA), working with the FDA and several other agencies, has launched a challenge for the scientific and data analytics communities to develop AI and machine learning (ML) models to predict cardiovascular health outcomes, including readmission and mortality. Read More
As the 118th Congress continues, FDAnews will be tracking the important pieces of pending legislation to keep you updated on regulations that could impact your business. Read More
Use of ethylene oxide (EtO) for medical device sterilization is safe for employees, neighbors and communities, and is the only viable method for many of the 20 billion devices it sterilizes each year, according to testimony given last week at the Environmental Protection Agency (EPA) public hearing on its proposal to reduce EtO from commercial sterilization facilities. Read More