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 ...

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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: ...

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the agency was looking to establish a risk-based framework for regulating lab-developed tests (LDTs) and released a draft guidance document to ...

Participants at the MedTech Forum in Sweden focused on the EMA’s newly launched innovative device pilot and the EU’s IVDR regulation.

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 ...

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 ...

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 ...

Dublin, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The "Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course (Apr 16th - Apr 17th, 2026)" training has been added to ...