Acute Otitis Media: Lessons Learned

7/19/02


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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1998 Draft Guidance: Study Considerations

1998 Draft Guidance: Study Considerations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1998 Draft Guidance: Study Considerations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1998 Draft Guidance: Inclusion Criteria

1998 Draft Guidance: Exclusion Criteria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1998 Draft Guidance: Evaluation and Outcome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

Author: CDER USER