Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...

This event focuses on two key areas in MedTech: the distinction between wellness and regulated health technologies, and the integration of artificial intelligence throughout the product lifecycle.

The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency@s Center for Drug Evaluation and Research (CDER ...

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Thousands of workers at the US Food and Drug Administration (FDA) were abruptly fired on 1 April as part of President Donald Trump@s effort to reduce the size of the federal government. Many agency ...

Clinical performance data for medical devices with artificial intelligence (AI) features is often unavailable, making it difficult to assess real-world outcomes and potentially jeopardizing safety, ...

The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School ...

While FDA experience is highly valued in the private industry, transitioning from the agency to private-sector employment requires new skills and a shift in mindset. This article provides resources ...

The regulatory environment of FSMPs in the EU has been previously well-described by Bushell. 61 The authors show the definition of FSMPS is broad enough to encompass a wide variety of FSMPs necessary ...

A US Food and Drug Administration (FDA) panel convened on Monday to explore the impact of selective serotonin reuptake inhibitors (SSRIs) on fetal development, with some panel members proposing that ...

This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions @ EU, UK, US, China, and other regions of the world @ ...