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AGENDA

Anti-Infective Drugs Advisory Committee

Food and Drug Administration
Ramada Inn, Bethesda, MD
Wednesday, March 5, 1997

OPEN SESSION
PART II

GUIDANCE TO INDUSTRY - EVALUATING CLINICAL STUDIES OF ANTIMICROBIALS IN THE DIVISION OF ANTI-INFECTIVE DRUG PRODUCTS EVALUABILITY CRITERIA FOR INDIVIDUAL INDICATIONS

2:00-3:00	Introduction		David Feigal, M.D., MPH
					Renata Albrecht, M.D. 
3:00-3:15	BREAK 
5:30-6:00	Open Public Hearing 
6:00 		ADJOURN 

 


Holiday Inn, Bethesda, MD
Thursday, March 6, 1997

OPEN SESSION

 

8:30-10:10 	PNEUMONIA	
		(Community-Acquired and Nosocomial) 
		FDA Presentation 	Luigi Girardi, M.D.
		Committee Presentation	William Craig, M.D.
		Discussion 
10:10-10:30	BREAK	
10:30-12:00	BRONCHITIS	
		(Acute Exacerbations of Chronic Bronchitis and 
		Secondary Bacterial Infections of Acute Bronchitis) 
		FDA Presentation	Susan Thompson, M.D. 
		Committee Presentation	William Craig, M.D. 
		Discussion 
12:00-1:00	LUNCH 
1:00-2:00	UNCOMPLICATED GONORRHEA 
		FDA Presentation	John Alexander, M.D. 
		Committee Presentation	Roselyn Rice, M.D. 
		Discussion 
2:00-3:15	ACUTE SINUSITIS	
		FDA Presentation	Renata Albrecht, M.D. 
		Committee Presentation	Jack Gwaltney, M.D. 
		Discussion 
3:15-3:30	BREAK 
3:30-5:00	ACUTE OTITIS MEDIA	
		FDA Presentation	Brad Leissa, M.D. 
		Committee Presentation	Marian Melish, M.D. 
					Richard Swartz, M.D. 
		Discussion 
5:00		ADJOURN 

Friday, March 7, 1997

OPEN SESSION

 

8:30-10:00	UNCOMPLICATED URINARY TRACT INFECTIONS	
		FDA Presentations	Janice Soreth, M.D. 
					Sousan Altaie, Ph.D. 
		Committee Presentation	Barth Reller, M.D. 
		Discussion 
10:05-10:20	BREAK 
10:20-12:00	SKIN AND SKIN STRUCTURE 
		(Uncomplicated and Complicated) 
		FDA Presentation	Alexander Rakowsky, M.D. 
		Committee Presentation	Carmelita Tuazon, M.D.
		Discussion 
12:00		ADJOURN 

Date created: June 3, 1997; last update: July 8, 2005

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