Food and Drug Administration

Anesthetic & Life Support Drugs Advisory Committee

November 18, 2003

Briefing Information

Table of Contents (PDF)

Overview Memorandum (PDF)

World Health Organization Newsletter (PDF)

Important Safety Message: Discontinuation of Droleptan tablets, suspension and injection (droperidol) (PDF)

FDA Talk Paper (PDF)

Health Care Provider Letter of 12/04/01(PDF)

Droperidol Insert Prior to 12/01 (PDF)

Droperidol Insert After 12/01 (PDF)

American Society of Anesthesiologists Newletter (PDF)

American Society of Anesthesiologists Newletter Update (PDF)

21 CFR Ch. 1 (PDF)

CPMP Points to Consider (PDF)

FDA Concept Paper (PDF)

ICH S7B (PDF)

Bibliography (HTM) (PDF) (Word)