| |
| FDA Official and Title | Date and Site | Other FDA Participants | Non-FDA Participants | Subject |
---|---|---|---|---|---|
Marlene E. Haffner,MD, MPH, Director Office of Orphan Products Development | 9/6 Rockville, MD | John McCormick, MD; Henry Startzman, MD | Edward Lemanowicz, Ag Hanzas, Frank J. Sasinowski, C.Kenneth Mehring, all from Sigma Tau Pharm | An orphan Drug | |
Dr. David Feigal, Jr., Director, Center for Devices and Radiological Health (CDRH) | 9/10/99 Corporate Blvd. Rockville, MD | Dr. Elizabeth Jacobson, Dr. Susan Alpert, Larry Kessler, Sc.D., Christy Foreman, Lillian Gill, and Brenda Hayden all from CDRH | Scott Remes, Mallinckrodt, Inc.; Robert Sheridan, C.L. McIntosh; Phillip Porte, Steven Zimmet, M.D., NAMDRC; Robert Rakers, Erie Medical; Marcia Nusgart, Coalition of Respiratory Care Mfg; Richard C. Klopstad, ReGin Manufacturing; Robert Sever, Essex Medical Systems Plus | Coalition of Respiratory Care Mfg., interests/issues: Oxygen Regulators/use, risks and experience; FDA actions; Solutions to problems |
September 13, 1999