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 FDA-regulated research....more
7/12/2023
/ Audits ,
Biotechnology ,
Clinical Trials ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Inspections ,
Institutional Review Board (IRB) ,
Investigational New Drug Application (IND) ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Sponsors
On May 2, 2023, the U.S. Food and Drug Administration (“FDA”) published draft guidance titled “Decentralized Clinical Trials for Drugs, Biological Products, and Devices” (the “Draft Guidance”). ...more