FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE (AIDAC) MEETING
QUESTIONS TO THE COMMITTEE
July 10, 2002
Marriott Washingtonian Center, Grand Ballroom, 9751 Washingtonian Blvd., Gaithersburg, MD
NDA 21-242, Artesunate Rectal Capsules, World Health Organization, proposed for the initial management of acute malaria in patients who cannot take medication by mouth and for whom parenteral treatment is not available
In your discussion, please include the usefulness of parasitemia as a measure of efficacy, the importance of recrudescence rates at Day 28, the related issue of follow-up therapy, and the importance of the differences in the study population and the intended use population.
If your answer to the above question is "No", please indicate what additional information would be required.
If your answer to the above question is "No", please indicate what additional information would be required.