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Drugs

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Clinical / Antimicrobial

 Title and Format  Type  Issue Date
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment(PDF - 422 KB) Draft 8/21/2008
Acute Bacterial Meningitis — Developing Antimicrobial Drugs for Treatment(PDF - 42 KB) Draft 7/22/1998
Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment (PDF - 155 KB) Draft 10/29/2007
Acute or Chronic Bacterial Prostatitis — Developing Antimicrobial Drugs for Treatment (PDF - 42 KB) Draft 7/22/1998
Acute Bacterial Otitis Media: Developing Drugs for Treatment (PDF - 173 KB) Draft 1/17/2008
Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval (PDF - 41 KB) Draft 10/12/2007
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency (PDF - 208 KB) Final 6/2/2006
Antiretroviral Drugs Using Plasma HIV RNA Measurements — Clinical Considerations for Accelerated and Traditional Approval  (PDF - 254 KB) Final 10/2002
Bacterial Vaginosis — Developing Antimicrobial Drugs for Treatment (PDF - 53 KB) Draft 7/22/1998
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs for Treatment (PDF - 54 KB) Draft 10/1999
Clinical Development and Labeling of Anti-Infective Drug Products  (PDF - 5 MB) Final 10/1992 Revised 2/12/2001
Clinical Evaluation of Anti-Infective Drugs (Systemic)(PDF - 1 MB) Final  9/77
Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment (PDF - 418 KB) Draft 3/19/2009
Complicated Urinary Tract Infections and Pyelonephritis — Developing Antimicrobial Drugs for Treatment  (PDF - 35 KB) Draft 7/22/1998
Developing Antimicrobial Drugs — General Considerations for Clinical Trials (PDF - 134 KB) [Main Document] Draft 7/22/1998
Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure) --  (PDF - 51 KB) Draft 3/15/2002
Empiric Therapy of Febrile Neutropenia — Developing Antimicrobial Drugs for Treatment (PDF - 33 KB) Draft 7/22/1998
Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (PDF - 267 KB) Draft 2/18/1997
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (PDF - 145 KB) Draft 10/2/2009
Influenza: Developing Drugs for Treatment and/or Prophylaxis(PDF - 225 KB) Draft 2/19/2009
Lyme Disease — Developing Antimicrobial Drugs for Treatment (PDF - 42 KB) Draft 7/22/1998
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF - 272 KB) Draft 9/16/2009
Nosocomial Pneumonia — Developing Antimicrobial Drugs for Treatment (PDF - 49 KB) Draft 7/22/1998
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (PDF - 244 KB) Final
 10/30/2007
Secondary Bacterial Infections of Acute Bronchitis — Developing Antimicrobial Drugs for Treatment (PDF - 10 KB) Draft 7/22/1998
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 257 KB) Draft 11/21/2007
Streptococcal Pharyngitis and Tonsillitis — Developing Antimicrobial Drugs for Treatment (PDF - 29 KB) Draft 7/22/1998
Uncomplicated and Complicated Skin and Skin Structure Infections — Developing Antimicrobial Drugs for Treatment  (PDF - 49 KB) Draft 7/22/1998
Uncomplicated Gonorrhea — Developing Antimicrobial Drugs for Treatment (PDF - 30 KB) Draft 7/22/1998,
Uncomplicated Urinary Tract Infections — Developing Antimicrobial Drugs for Treatment (PDF - 42 KB) Draft 7/22/1998
Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination  (PDF - 139 KB) Draft 3/8/2004
Vulvovaginal Candidiasis — Developing Antimicrobial Drugs for Treatment (PDF - 42 KB) Draft 7/22/1998
    
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