AGENDA

Anti-Infective Drugs Advisory Committee

Food and Drug Administration
Hilton Hotel, Gaithersburg MD

OPEN SESSION

GUIDANCE TO INDUSTRY
DEVELOPING ANTIMICROBIAL DRUGS -- GENERAL CONSIDERATIONS FOR CLINICAL TRIALS

Wednesday, July 29, 1998 (transcript)

8:00-8:10         Opening Remarks              William Craig, MD, Chair8:10-8:15         Conflict statement           Ermona McGoodwin

8:15-8:45         Guidance development         Renata Albrecht, MD

8:45-9:00         Welcome & FDAMA Summary      Dianne Murphy, MD

9:00-9:15         Introduction                 Gary Chikami, MD9:15-10:15        Biostatistics                Daphne Lin, PhD
                  Discussant:                  Janet Wittes, PhD10:15-10:30       Coffee break10:30-12:00       Bacterial meningitis         Alex Rakowsky, MD
                  Discussant:                  Joan Chesney, MD12:00-1:00        Lunch1:00-2:30         Acute Otitis Media           Brad Leissa, MD
                  Discussant:                  Joan Chesney, MD2:30-4:00         Vulvovaginal candidiasis     Joseph Winfield, MD
                  Discussant:                  David Soper, MD4:00-4:15         Coffee break4:15-5:30         Bacterial vaginosis          Dan Davis, MD,MPH
                  Discussant:                  David Soper, MD5:30              Adjourn

Thursday, July 30, 1998 (transcript)

8:00-8:10         Opening remarks              William Craig, MD

8:10-9:15         Complicated UTI & pyelo      Regina Alivisatos, MD
                  Discussant:                  Barth Reller, MD9:15-9:45         General Clinical             Renata Albrecht, MD9:45-11:00        Prostatitis                  Regina Alivisatos, MD
                  Discussant:                  William Craig, MD11:00-11:15       Coffee break11:15-12:15       Streptococcal pharyngitis    Mamodikoe Makhene, MD
                  and tonsillitis
                  Discussant:                  Celia Christie, MD12:15-1:15        Lunch1:15-1:45         Open public hearing

1:45-3:15         Early Lyme disease           Janice Soreth, MD
                                               Sousan Altaie, PhD
                  Discussant:                  Raymond Dattwyler, MD

3:15-3:30         Coffee break3:30-4:00         Sinusitis                    Eric Mann, MD,PhD
                  Discussant:                  Committee4:00-4:30         Bronchitis                   David Bostwick
                  Discussant:                  William Craig, MD4:30-5:00         Pneumonia (CAP & HAP)        Alma Davidson, MD
                  Discussant:                  William Craig, MD5:00-5:30         Sputum Gram stain            Sousan Altaie, PhD
                  Discussant:                  Barth Reller, MD5:30              Adjourn

Friday, July 31, 1998 (transcript)

8:00-8:15         Opening remarks              William Craig, MD

8:15-8:30         Toxicology update            Robert Osterberg, RPh,PhD

8:30-9:00         Microbiology update          Sousan Altaie, PhD9:00-9:45         Clinical Pharmacology        Phil Colangelo, PhD
                  Discussant:                  William Craig, MD9:45-10:00        Coffee break10:00-12:00       Empirical therapy of         David Ross, MD
                  febrile neutropenia
                  Discussant:                  Arthur Brown, MD12:00-1:00        Lunch1:00-1:30         Open public hearing1:30              Adjourn

Last update: July 8, 2005

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research