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    Congressmen Question FDA Over Office of Laboratory Safety

    Rep. Fred Upton (R-MI), chairman of the House Energy & Commerce Committee, and Rep. Tim Murphy (R-PA) sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday questioning why the agency has not formulated a budget request or level of staffing for its Office of Laboratory Safety. The letter follows an April hearing at which FDA said it has taken “direct and definitive actions” to improve lab safety. That hearing came as a report fro...
  • FDA Makes Changes to Bioresearch Monitoring Information System

    The US Food and Drug Administration (FDA) released new updates to the Bioresearch Monitoring Information System (BMIS) on 9 January.  The program is used by FDA to oversee regulated clinical trials. According to FDA, BMIS "provides controls to ensure that clinical investigators meet the requirements of the relevant statutes and regulations governing FDA-regulated products." This, in turn, supports the bioresearch monitoring (BIMO) program. The changes to BMIS ...