TAILIEUCHUNG - Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment

Indonesia has received GFATM grants since 2003 with 17 grants worth $500 million across the three diseases. Grants have been awarded to the MOH, National AIDS Commission and civil society partners. Grants to the MOH are used to procure all ARVs and many of the ACTs and MDR-TB treatment regimens in Indonesia. Programs strengthen and expand DOTS, train health workers, strengthen communications and community outreach, build the capacity of national, regional and provincial laboratories, improve quality and reach of service delivery, including opportunistic infections, TB/HIV coinfection, PMTCT, counseling and testing, enhance the health information system; support indoor residual spraying control. | Guidance for Industry Acute Bacterial Sinusitis Developing Drugs for Treatment . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER October 2012 Clinical Antimicrobial Guidance for Industry Acute Bacterial Sinusitis Developing Drugs for Treatment Additional copies are available from Office of Communications Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Bldg. 51 rm. 2201 Silver Spring MD 20993-0002 Tel 301-796-3400 Fax 301-847-8714 E-mail druginfo@ http Drugs GuidanceComplianceRegulatoryInformation Guidances . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER October 2012 Clinical Antimicrobial TABLE OF CONTENTS I. II. III. DEVELOPMENT A. General 1. Nonclinical Development 2. Drug Development 3. Efficacy 4. Safety B. Specific Efficacy Trial 1. Clinical Trial 2. Trial 3. Inclusion a. b. c. Generalized signs and 4. Exclusion 5. Additional Clinical Trial Entry a. b. Baseline sinus aspiration and 6. Randomization Stratification and 7. Special 8. Dose 9. Concomitant 10. Efficacy 11. Trial Visits and Timing of a. Entry b. On-therapy c. Early follow-up d. Late follow-up e. Safety 12. Statistical a. Analysis b. Noninferiority c. Sample d. Missing e. Statistical analysis 13. Ethical 14. Labeling .

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