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the agency was looking to establish a risk-based framework for regulating lab-developed tests (LDTs) and released a draft guidance document to ...
Two new guidance documents from the European Commission’s Medical Device Coordination Group (MDCG) aim to provide more information on applying new medtech regulations. First up is the guidance to ...
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro ...
HiMedia is dedicated to maintaining high safety, quality, and performance standards for in-vitro diagnostic products used in healthcare. This commitment significantly enhances the well-being of ...
A highly accurate new tool for the direct detection of HPV mRNA in FFPE tissue specimens MINNEAPOLIS, July 6, 2022 /PRNewswire/ -- Bio-Techne (NASDAQ: TECH), a global life sciences company providing ...
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