Food and Drug Administration

Drug Safety and Risk Management Advisory Committee

September 18, 2003

Briefing Information

Letter to Committee Members, Dr. Victor Raczkowski, MD, MS, FDA (HTM) (PDF) (Word)

Executive Summary (HTM) (PDF) (Word)

Post Marketing Safety Review (HTM) (PDF) (Word)

Congressional Letter, Tom Harkin, Senator (PDF)

Institute for Safety Medication Practices Medication Safety Alert, May 15, 2002 (HTM) (PDF) (Word)

Letter Regarding Plastic Ampul Labeling, Eric Sheinin, USP Pharmacopeio (HTM) (PDF) (Word)

Guidance for Industry - Inhalation Drug Products Packaged in Semipermeable Container Closure Systems (PDF)

Please Link to Docket Number 02D-0254 for Comments on the Low Density Polyethylene Guidance

Federal Register Notice, Vol. 68, No. 125, Monday, June 30, 2003 (PDF)

Labeling Regulations

21 CFR 201.10 Drugs; Statement of Ingredients (PDF)

21 CFR 201.15 Drugs; Prominence of REquired Label Statements (PDF)

21 CFR 201.17 Drugs; Location of Expiration Date (PDF)