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Preliminary research showed that the Mirvie RNA platform can identify 75 percent of women who go on to develop preeclampsia, months before symptoms occur. Read More
MIVI Neuroscience received a Form 483 with three observations for inadequate corrective and preventive action (CAPA) activities and documentation issues observed during an FDA inspection of the company’s facility in Eden Prairie, Minn., last December. Read More
Companies that market in vitro diagnostic devices (IVDs) in the EU may continue to use existing certificates after the EU’s new In Vitro Diagnostics Regulation (IVDR) goes into effect on May 26 as long as they do not make “significant” changes to the products’ design or intended purposes. Read More
The FDA on Friday issued a draft guidance on its Voluntary Improvement Program (VIP), which uses third-party quality appraisals to help manufacturers improve their production and quality practices, signaling VIP’s transition from a pilot to a permanent program. Read More