Food and Drug Administration

Drug Safety and Risk Management Advisory Committee

May 5, 2004


Permeability of LDPE Vials: A Clinical Perspective, Dr. Eugene Sullivan, MD FCCP, FDA (HTM) (PPT)

Inhalation Drug Products in LDPE Containers: A Quality (CMC) Perspective, Dr. Vibhakar Shah, PhD, FDA (HTM) (PPT)

Medication Errors and Low-Density Polyethylene (LDPE) Plastic Vials, Dr. Marci Lee, PharmD, FDA (HTM) (PPT)

Container Labeling Options Using Rommelag® Blow Fill Seal Technology, Mohammad Sadephi, Holopack Int'l. Corp. (HTM) (PPT)

Labeling of LDPE Containers: Options for Improving Identification for Prevention of Medication Errors, Rick Schindewolf and Patrick Poisson, CardinalHealth (HTM) (PPT)

Statment by American Association for Respiratory Care, Karen Stewart, MS RRT (HTM) (PPT)

Statement By Karen Stewart (HTM) (PDF) (Word)

Low Density Polyethylene Vials (LDPE), Dr. Paul Seligman, MD, MPH, FDA (HTM) (PPT)

Risk Management Program for Lotronex® (Alosetron Hydrochloride) Tablets, Dr. Craig Metz, PhD, GlaxoSmithKline (HTM) (PPT)

Lotronex Update, Dr. Robert Justice, MD, MS, FDA (HTM) (PPT)

Open Public Hearing

USP Presentation on Medication Errors Relating to the Labeling and Packaging of Various Drug Products in Low-Density Polyethylene Plastic Vials, Dr. Eric Sheinin, PhD, US Pharmacopeia (PDF)