HELPFUL LINKS : Drug Approvals and Databases
Clinical Investigator Inspection List (CLIIL)
WHAT : Names, addresses, pertinent information FDA inspections of clinical investigators
WHEN : August 1977-present, updated quarterly
WHO : CDER
Bioresearch Monitoring Information System (BMIS)
WHAT : Clinical investigators, contract research organizations, and institutional review boards involved in IND studies, Based on information from 1572
WHEN : Updated quarterly
WHO : CDER
NEW OFFICE: Office of Dietary Supplement Programs (ODSP)
WHY : Need to take action against fraudulent supplements that can cause serious risk to consumer (e.g. egregious benefit claims in treating serious diseases) or widespread economic fraud.
WHAT : Newly created; to enhance effectiveness of dietary supplement regulation
WHO : Under CFSAN, will work closely with CDER to help remove falsely labeled supplements