Institutional Review Boards (IRBs) play a key role in research oversight. Their job goes far beyond reviewing study designs and consent forms. IRB members are responsible for protecting the rights, safety, and well-being of human subjects. But anothe
Conducting in vivo bioequivalence (BE) studies is a critical step for companies developing generic drugs. These studies compare a test product to a reference drug to show that both perform the same in the human body. The U.S. Food and Drug Administra
GUIDES: FDA Clinical Trial Compliance and GCP Inspection Readiness How to Prepare for an FDA BIMO InspectionA Clinical Investigator's Compliance Guide The FDA's Bioresearch Monitoring (BIMO) program conducted more than 1,000 inspections in FY
