TAILIEUCHUNG - Guidance for Industry Acute Bacterial Otitis Media: Developing Drugs for Treatment

The most important accomplishment of the European Union is that it made war among its members impossible. Their in- terconnected economies have led to unprecedented prosperity for the EU’s 4 5 million citizens and have created the most profitable consumer market in the world. Other regional or- ganisations are studying the model of the EU, and may choose some elements – even if they are unlikely to adopt the same model, because no nation seeking to increase its economic power would be willing to see its national sovereignty dimin- ished. The regional integration of Europe has led to nations transfer- ring some of their national sovereignty. | Guidance for Industry Acute Bacterial Otitis Media Developing Drugs for Treatment . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER September 2012 Clinical Antimicrobial Guidance for Industry Acute Bacterial Otitis Media 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 September 2012 Clinical Antimicrobial TABLE OF CONTENTS I. II. III. DEVELOPMENT A. General 1. Early Phase Clinical Development a. Nonclinical b. Animal c. Efficacy outcome measure 2. Drug Development 3. Efficacy 4. Safety B. Specific Efficacy Trial 1. Trial a. Active-controlled clinical b. Placebo-controlled clinical 2. Clinical Trial 3. Entry a. Patient history and b. Symptoms and observable c. Clinical d. Baseline e. Exclusion 4. Randomization Stratification and 5. Dose 6. Choice of 7. Concomitant 8. Efficacy 9. Trial Procedures and Timing of a. Entry b. On-therapy c. Early follow-up d. Late follow-up 10. Statistical a. Analysis b. Sample c. Missing d. Interim analyses and data monitoring e. Other .

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