FDA Consultation in Developing PDUFA IV Recommendations
| Date Time Length | Subjects | Participants |
|---|---|---|
| 11/14/05 9:00 to 5:00 PM 8 Hours | What is your assessment of the overall performance of the PDUFA program so far and what aspects of PDUFA should be retained and what should be changed to strengthen the PDUFA program? | FDA: Andrew von Eschenbach, OC Scott Gottlieb, OC Janet Woodcock, OC Steven Galson, CDER Jesse Goodman, CBER Deborah Henderson, CDER ACADEMIC RESEARCH: Kenneth Kaitin, Tufts Center for the Study of Drug Development Raymond L. Woosley, The Critical Path Institute, University of Arizona Ernst R. Berndt, MIT Sloan School of Management and National Bureau of Economic Research Program on Technical Progress and Productivity Measurement High Tilson, Centers for Education and Research on Therapeutics PATIENTS: Perry Cohen, Parkinsons Pipeline Project Diane Dorman, National Organization for Rare Disorders Jeanne Ireland, Elizabeth Glaser Pediatric AIDS Foundation Ellen Sigal, Friends of Cancer Research CONSUMERS: Alison Rein, National Consumers League William Vaughan, Consumers Union Arthur Levin, Center for Medical Consumers Diana Zuckerman, National Research Center for Women & Families Amy Allina, National Women's Health Network HEALTH PROFESSIONALS: Carole Redding Flamm, Blue Cross/Blue Shield Association Judith Cahill, Academy of Managed Care Pharmacy Susan Winckler, American Pharmaceutical Association Allen Vaida, Institute for Safe Medication Practices William Zellmer, American Society of Health-System Pharmacists INDUSTRY: Alison Lawton, Biotechnology Industry Organization (BIO) Bruce Burlington, Wyeth/Pharmaceutical Research and Manufacturers of America [PhRMA] Mary Gustafson, Plasma Protein Therapeutics Association Alan Kirschenbaum on behalf of Council on Radionuclides and Radiopharmaceuticals Milton Ellis, Rare Disease Therapeutics Milt Hench, Regent Medical OTHER: Bill Rosen, Clinical Data Interchange Standards Consortium |
| 5/22/06 9:00 to 11:00 AM 2 Hours |
| FDA: Janet Woodcock, OC Theresa Mullin, OPPL Steven Galson, CDER Jesse Goodman, CBER Douglas Throckmorton, CDER Robert Yetter, CBER Theresa Toigo, OER Patricia Kuntze, OER Patricia Stewart, OPPL PATIENTS: Jennifer Taylor McBride, Arthritis Foundation Perry Cohen, Parkinson Pipeline Project Elridge Proctor, Tourette Syndrome Association Jeff Coughlin, Jeff Allen, Friends of Cancer Research Shawn O'Neaill, National MS Society Kara Lee-Burton, Mark Del Monte, Suzanne Palinski, American Academy of Pediatrics Martha Nolan, Society for Women's Health Research Megan Moore, Diane Dorman, National Organization for Rare Disorders Mary Richards, Parkinsons Action Network Leslie Hanrahan, The Lupus Foundation of America Roberta Biegel, National Osteoporosis Foundation George Dahlman, The Leukemia & Lymphoma Society Jayne E. Murdock, National Kidney Foundation |
| 5/23/06 2:00 to 4:00 PM 2 Hours |
| FDA: Kathleen Heuer, OM Randy Lutter, OPPL Janet Woodcock, OC Theresa Mullin, OPPL Douglas Throckmorton, CDER Robert Yetter, CBER Patricia Kuntze, OER Patricia Stewart, OPPL Theresa Toigo, OER CONSUMERS: Lee Rucker, AARP Arthur Levin, Center for Medical Consumers Merrill Goozner, Center for Science in the Public Interest William Vaughan, Consumers Union Mark Cohen, Government Accountability Project Alison Rein, National Consumers League Diana Zuckerman, National Research Center for Women & Families Lindsey Wade, National Research Center for Women & Families Amy Allina, National Women's Health Network Jeff Bloom, Title II Community AIDS National Network Paul Brown, US Public Interest Research Group |
| 6/23/06 1:00 to 3:00 PM 2 Hours |
| FDA: Janet Woodcock, OC Randall Lutter, OPPL Theresa Mullin, OPPL Jesse Goodman, CBER Paul Seligman, CDER Terry Toigo, OER Brenda Evelyn, OER Patricia Stewart, OPPL Kristen Smith, OC MEDICAL COMMUNITY: Judith Cahill, William Hermelin, Marissa Schlaifer, Academy of Managed Care Pharmacy Joseph Cranston, American Medical Association Mark Del Monte, Kara Lee-Brunton, American Academy of Pediatrics Michael Ellwood, American Academy of Physician Assistants Pamela Ferraro, Shelagh Foster, American Society of Hematology G. Brockwel Heylin, American Association of Clinical Endocrinologists Angela Jeansonne, American Osteopathic Association Neil Kirschner, American College of Physicians Sarah Matthew, American Association of Colleges of Pharmacy Sara Mechum, American Academy of Child & Adolescent Psychiatry Claudia Soho, American Society of Clinical Oncology Susan Winckler, The American Pharmacists Association Kim Wittenberg, Association of American Medical Colleges |