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...
Coronavirus delays many FDA foreign inspections

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Comments in response to the US Food and Drug Administration (FDA)’s draft guidance on software assurance for computer and data processing systems associated with...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 – FDA clarifies definition of devices vs. counterfeit devices

The US Food and Drug Administration has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act....

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...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

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...
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications

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...

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