Food and Drug Administration
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)