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 ...

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 ...

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 Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...

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 @ ...

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) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...

Health and Human Services (HHS) Secretary Robert Kennedy Jr. announced on Wednesday that the Emergency Use Authorizations (EUA) for all COVID-19 vaccines have been rescinded, coinciding with the ...

This article reviews the changes in China@s national food safety control system and update on national food safety standard system and describes the country@s unique regulations and requirements for ...

There is an expectation that number of Phase IV studies being conducted in India will increase. This expectation is based on the assumption that with local clinical trial waiver, a Phase IV study ...

During a joint workshop on Monday, officials from the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) outlined efforts to reduce animal testing. FDA Commissioner Marty ...