Food and Drug Administration

Drug Safety & Risk Management Advisory Committee

May 5, 2004

Briefing Information

Welcome Letter to the Committee Members (HTM) (PDF) (Word)

Executive Summary - Safe Use of Drug Products Packaged in Low Density Polyethylene (LDPE) Containers (HTM) (PDF) (Word)

Draft Issues for Discussion (HTM) (PDF) (Word)

Post-Marketing Safety Review (PDF)

Congressional Letter, Tom Harkin, US Senator (PDF)

ISMP Medication Safety Alert (HTM) (PDF) (Word)

Letter Regarding Plastic Ampul Labeling, US Pharmacopeia (HTM) (PDF) (Word)

Guidance for Industry: Inhalation Drug Products Packaged in Semipermeable Container closure Systems (PDF)

Public Comments (PDF)

21 CFR Ch.§201.10 Drugs; Statement of Ingredients (PDF)

21 CFR Ch.§201.15 (PDF)

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

Lotronex® (Alosetron Hydrochloride) Tablets, GlaxoSmithKline (PDF)

Lotronex® & Its Risk Management Plan Cover Page, FDA (HTM) (PDF) (Word)

Table of Contents, FDA (HTM) (PDF) (Word)

Update on Risk Management Activities for Lotronex (alosetron hydrochloride), FDA (HTM) (PDF) (Word)

Lotronex Risk Management Program (PDF)

Lotronex® (alosetron hyochloride) Tablets, Production Information (PDF)

Letter to GlaxoSmithKline, FDA (PDF)

Memorandum Regarding ODS Postmarketing Safety Review of the Drug Alosetron (Lotronex) (PDF)

Addendum to FDA Briefing Document - Errata (PDF)