The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all ...
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 ...
The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the ...
The U.S. FDA should audit the hiring practices of its Bioresearch Monitoring (BIMO) program to see whether efforts to attract more investigators and boost drug trial oversight are paying off, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results