HELPFUL LINKS : Drug Approvals and Databases

LINK

databases

Clinical Investigator Inspection List (CLIIL)

WHAT : Names, addresses, pertinent information FDA inspections of clinical investigators

WHEN : August 1977-present,  updated quarterly

WHO : CDER

LINK

CLIL

 

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

LINK

BMIS

 

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

LINK

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