Dublin, Dec. 29, 2021 (GLOBE NEWSWIRE) -- The "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in ...

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the agency was looking to establish a risk-based framework for regulating lab-developed tests (LDTs) and released a draft guidance document to ...

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STOCKHOLM , Aug. 29, 2022 /PRNewswire/ -- Devyser has today been certified under the new, more comprehensive IVD Regulation that came into force on May 26, 2022. The certification, issued by the ...

The new In Vitro Diagnostic Regulation (IVDR) has been defined as one of the most significant changes in the EU legislation for In Vitro Diagnostics in the past 20 years. Due to the nature of the ...

2cureX, a company pioneering the use of 3D tumoroids for drug sensitivity prediction in patients with cancer, announced today the signature of a contract with a Notified Body under Regulation (EU) ...

DUBLIN--(BUSINESS WIRE)--The "Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada" ...

On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework ...

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 ...