The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new ...
U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how ...
Stakeholders are taking issue with the US Food and Drug Administration’s (FDA) draft guidance on conducting bioresearch monitoring (BIMO) inspections. They are particularly concerned about protecting ...
An FDA field investigator leaves your site after spending five days scrutinizing your device clinical trial records, interviewing study staff, asking pointed and open-ended questions, and reviewing ...
The US Food and Drug Administration (FDA) should examine its methods for recruiting and retaining Bioresearch Monitoring (BIMO) investigators, according to a recent report from the Government ...
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