Food and Drug Administration

Anti-Infective Drugs Advisory Committee

Briefing Information

July 11, 2002

Clinical Trial Design in Otitis Media: an Overview   pdf   htm   doc

Guidance for Industry:  Guidelines for the Clinical Evaluation of Anti-Infective Drugs-Systemic (Adults and Children), September 1977   pdf

Guidance for Industry:   Acute Otitis Media -- Developing Antimicrobial Drugs for Treatment, Draft Guidance, July 1998   pdf