IVDs are essential for disease detection, personalized treatment, and public health, driving growth in the global diagnostics ...

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In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: ...

Medical device regulators launched new initiatives on harmonizing in vitro diagnostic (IVD) regulations and tweaking the Medical Device Single Review Program (MDSAP) for additional countries to ...

In 2013, FDA Commissioner Margaret Hamburg announced that the agency was looking to establish a risk-based framework for regulating lab-developed tests (LDTs) and released a draft guidance document to ...

Historically, pharmaceutical and diagnostic companies in the U.S. have inhabited parallel regulatory universes. Although both sets of firms are overseen by the FDA and are subject to some identical ...

Dublin, Aug. 07, 2025 (GLOBE NEWSWIRE) -- The "Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course" has been added to ResearchAndMarkets.com's offering. The In-Vitro Diagnostic ...

insights from industryLaura NeaVP of Quality and Regulatory ManagementTecan In this interview, News-Medical talks to Laura Nea, Vice President of Quality and Regulatory Management at Tecan, about the ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

Australia’s Therapeutic Goods Administration (TGA) issued a consultation paper on Tuesday to propose a new framework for the regulation of companion in vitro diagnostic (IVD) devices. The framework ...

DUBLIN--(BUSINESS WIRE)--The "China IVD Market Size, Share, Trends, Regulations, Reimbursement & Company Analysis - Forecast to 2024" report has been added to ResearchAndMarkets.com's offering. China ...