USA – Theranos : onze ans de prison contre Elizabeth Holmes, patronne déchue, condamnée...
L’ancienne star de la Silicon Valley Elizabeth Holmes, reconnue coupable de fraude en janvier, a été fixée sur sa peine, vendredi 18 novembre, près de...
USA – FDA rules on definitions of device; issues revised form for reporting adverse...
The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends...
USA – Industry seeks clarity, ICH Q9 alignment in FDA’s device production software...
Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with...
USA – Quinze ans de prison requis contre Elizabeth Holmes, fondatrice de Theranos
Les procureurs ont requis 15 ans de prison contre Elizabeth Holmes, star déchue de la Silicon Valley, tandis que la défense a plaidé pour une...
USA – Action needed on FDA regulation of AI-based medical devices
After lagging other sectors for years, the era of artificial intelligence (AI) in healthcare is dawning as its use is becoming more prevalent in a variety...
USA – FDA advisors want standards, labeling to address racial disparities with pulse oximeters
A panel of external US Food and Drug Administration (FDA) experts are urging more research to improve the efficacy of pulse oximeters in people...
USA – FDA updates guidance on identifying and responding to deficiencies
The US Food and Drug Administration has revised the guidance document Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions to update the...
USA – FDA Denies Marketing of Logic’s Menthol E-Cigarette Products Following Determination They Do...
Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for several e-cigarette products currently marketed by Logic Technology Development LLC (Logic). The...
USA – FDA proposes updates to Breakthrough Devices Program guidance
The US Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance, expanding its...
USA – FDA issues road map to medical device regulatory guidance topics list for...
The US Food and Drug Administration has released a list of guidance documents it plans to issue over its 2023 fiscal year. FDA’s Center...
