Table of Contents
Acute Otitis Media: Lessons Learned
1998 Draft Guidance: Study Considerations
1998 Draft Guidance: Study Considerations
Example: Clinical-only Trial
Clinical-only Trial: MITT Outcomes
Example: Tympanocentesis Trial
Tympanocentesis Trial: Outcomes by Pathogen
Comments from Advisory Committee, November 2001
Pediatric Infectious Disease Journal Newsletter, February 2002
Pediatric Infectious Disease Journal Newsletter, February 2002
Issues for Discussion
1998 Draft Guidance: Study Considerations
Example: Pathogen Labeling
Example: Pathogen Labeling
Issues for Discussion
1998 Draft Guidance: Inclusion Criteria
1998 Draft Guidance: Exclusion Criteria
Issues for Discussion
1998 Draft Guidance: Evaluation and Outcome
Advisory Committee, January 2001
Summary: Issues for Discussion
Summary: Issues for Discussion
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