Clinical / Antimicrobial
|
Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment (PDF - 210KB)
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Draft Guidance
|
08/22/08
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Clinical / Antimicrobial
|
Acute Bacterial Meningitis — Developing Antimicrobial Drugs for Treatment (PDF - 42KB)
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Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment (PDF - 129KB)
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Draft Guidance
|
10/30/07
|
Clinical/Antimicrobial
|
Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment (PDF - 516KB)
|
Draft Guidance
|
08/26/10
|
Clinical / Antimicrobial
|
Acute or Chronic Bacterial Prostatitis — Developing Antimicrobial Drugs for Treatment (PDF - 42KB)
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Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Acute Bacterial Otitis Media: Developing Drugs for Treatment (PDF - 198KB)
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Draft Guidance
|
01/18/08
|
Clinical/Antimicrobial
|
Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval (PDF - 83KB)
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Final Guidance
|
11/26/10
|
Clinical/Antimicrobial
|
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency (PDF - 100KB)
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Final Guidance
|
06/02/06
|
Clinical/Antimicrobial
|
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data (PDF - 293KB)
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Final Guidance
|
06/02/06
|
Clinical/Antimicrobial
|
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency : Guidance for Submitting Influenza Resistance Data (PDF - 385KB)
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Final Guidance
|
06/02/06
|
Clinical/Antimicrobial
|
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HBV Resistance Data (PDF - 123KB)
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Final Guidance
|
06/02/06
|
Clinical/Antimicrobial
|
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data (PDF - 122KB)
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Final Guidance
|
06/02/06
|
Clinical/Antimicrobial
|
Antiretroviral Drugs Using Plasma HIV RNA Measurements — Clinical Considerations for Accelerated and Traditional Approval (PDF - 254KB)
|
Final Guidance
|
10/01/02
|
Clinical / Antimicrobial
|
Bacterial Vaginosis — Developing Antimicrobial Drugs for Treatment (PDF - 53KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Catheter-Related Bloodstream Infections - Developing Antimicrobial Drugs for Treatment (PDF - 54KB)
|
Draft Guidance
|
10/18/99
|
Clinical / Antimicrobial
|
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment (PDF - 306KB)
|
Draft Guidance
|
09/14/10
|
Clinical/Antimicrobial
|
Clinical Development and Labeling of Anti-Infective Drug Products (PDF - 5.1MB)
|
Final Guidance
|
02/12/01
|
Clinical/Antimicrobial
|
Clinical Evaluation of Anti-Infective Drugs (Systemic) (PDF - 1.1MB)
|
Final Guidance
|
09/01/77
|
Clinical / Antimicrobial
|
Community-Acquired Pneumonia — Developing Antimicrobial Drugs for Treatment (PDF - 418KB)
|
Draft Guidance
|
03/20/09
|
Clinical / Antimicrobial
|
Complicated Urinary Tract Infections: Developing Drugs for Treatment (PDF - 665KB)
|
Draft Guidance
|
02/23/12
|
Clinical / Antimicrobial
|
Developing Antimicrobial Drugs — General Considerations for Clinical Trials (PDF - 134KB)
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Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Developing Antimicrobial Drugs to Treat Inhalational Anthrax (Post Exposure) (PDF - 250KB)
|
Draft Guidance
|
03/15/02
|
Clinical / Antimicrobial
|
Empiric Therapy of Febrile Neutropenia — Developing Antimicrobial Drugs for Treatment (PDF - 33KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Evaluating Clinical Studies Of Antimicrobials In The Division Of Anti-Infective Drug Products (PDF - 267KB)
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Draft Guidance
|
02/17/97
|
Clinical / Antimicrobial
|
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (PDF - 145KB)
|
Draft Guidance
|
10/05/09
|
Clinical / Antimicrobial
|
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment (PDF - 461KB)
|
Draft Guidance
|
11/26/10
|
Clinical / Antimicrobial
|
Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF - 417KB)
|
Final Guidance
|
04/12/11
|
Clinical / Antimicrobial
|
Lyme Disease — Developing Antimicrobial Drugs for Treatment (PDF - 42KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF - 272KB)
|
Draft Guidance
|
09/17/09
|
Clinical/Antimicrobial
|
Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (PDF - 194KB)
|
Draft Guidance
|
08/23/11
|
Clinical/Antimicrobial
|
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (PDF - 244KB)
|
Final Guidance
|
10/30/07
|
Clinical / Antimicrobial
|
Secondary Bacterial Infections of Acute Bronchitis — Developing Antimicrobial Drugs for Treatment (PDF - 10KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 242KB)
|
Draft Guidance
|
11/23/07
|
Clinical / Antimicrobial
|
Streptococcal Pharyngitis and Tonsillitis — Developing Antimicrobial Drugs for Treatment (PDF - 29KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Uncomplicated Gonorrhea — Developing Antimicrobial Drugs for Treatment (PDF - 30KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Uncomplicated Urinary Tract Infections — Developing Antimicrobial Drugs for Treatment (PDF - 42KB)
|
Draft Guidance
|
07/22/98
|
Clinical / Antimicrobial
|
Vaccinia Virus — Developing Drugs to Mitigate Complications from Smallpox Vaccination (PDF - 139KB)
|
Draft Guidance
|
03/09/04
|
Clinical / Antimicrobial
|
Vulvovaginal Candidiasis — Developing Antimicrobial Drugs for Treatment (PDF - 42KB)
|
Draft Guidance
|
07/22/98
|