Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee

June 10, 2004

Slides

History of the Montreal Protocol and 21 CFR 1.125, Dr. Robert Meyer, MD, FDA (HTM) (PPT)

CFC Essential Use of Status of Albuterol: Medical Considerations, Dr. Eugene Sullivan, MD, FCCP, FDA (HTM) (PPT)

Delisting Albuterol CFCs: Economic Considerations, Dr. Randall Lutter, PhD, FDA (HTM) (PPT)

Topics for Discussion (HTM) (PPT)

Open Public Hearing

Session 1 - AM Speakers (HTM) (PPT)

Removing the Essential Use Designation for Albuterol, US Stakeholders Group on MDI Transition, Dr. Pamela Wexler, MD (HTM) (PPT)

Session 2 - PM Speakers (HTM) (PPT)

Presentation by IVAX Corp., Neil Flanzraich (HTM) (PPT)

Presentation by NERA Economic Consultion, Richard Rozek (HTM) (PPT)

Helping Patients Breathe More Easily With Affordable Prescriptions, Asthma Therapy Coalition (HTM) (PPT)

Asthma Inhalers, Allergy & Asthma Network (HTM) (PPT)

Comments of the American College of Allergy, Asthma and Immunology, Dr. Ira Finegold (HTM) (PPT)