Drugs

Clinical / Antimicrobial

Below is a sortable table of Clinical/Antimicrobial Guidances:

CategoryTitleTypeDate
Clinical/Antimicrobial Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment (PDF - 267KB) Final Guidance 10/16/13
Clinical/Antimicrobial Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval (PDF - 83KB) Final Guidance 11/26/10
Clinical/Antimicrobial Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases (PDF - 465KB) Draft Guidance 07/01/13
Clinical/Antimicrobial Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency (PDF - 100KB) 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 - 117KB) 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 - 108KB) 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 - 85KB) 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 - 128KB) Final Guidance 06/02/06
Clinical/Antimicrobial Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance (PDF - 391KB) Draft Guidance 02/22/13
Clinical/Antimicrobial Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (PDF - 609KB) Final guidance 11/02/15
Clinical / Antimicrobial Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment Guidance for Industry (PDF - 666KB) Draft Guidance 05/03/16
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Clinical / Antimicrobial Community-Acquired Pneumonia — Developing Antimicrobial Drugs for Treatment (PDF - 492KB) Draft Guidance 01/09/14
Clinical / Antimicrobial Complicated Urinary Tract Infections: Developing Drugs for Treatment (PDF - 366KB) Final Guidance 02/13/15
Clinical / Antimicrobial; Animal Rule Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax (PDF - 565KB) Draft Guidance 02/12/16
Clinical / Antimicrobial Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment (PDF - 148KB) Draft Guidance 10/05/09
Clinical / Antimicrobial Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment (PDF - 377KB) Draft Guidance 05/06/14
Clinical / Antimicrobial Influenza: Developing Drugs for Treatment and/or Prophylaxis (PDF - 417KB) Final Guidance 04/12/11
Clinical / Antimicrobial Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation (PDF - 249KB) Draft Guidance 09/17/09
Clinical/Antimicrobial Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (PDF - 364KB) Final Guidance 07/03/14
Clinical/Antimicrobial Role of HIV Drug Resistance Testing in Antiretroviral Drug Development (PDF - 238KB) Final Guidance 10/30/07
Clinical / Antimicrobial Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention (PDF - 242KB) Draft Guidance 11/23/07
Clinical/Antimicrobial Guidance for Industry Acute Bacterial Sinusitis: Developing Drugs for Treatment Final Guidance 10/05/12
Clinical Antimicrobial Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment Final Guidance 09/28/12
Clinical/Antimicrobial Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for Treatment Final Guidance 10/01/12
Clinical/Antimicrobial Pulmonary Tuberculosis: Developing Drugs for Treatment (PDF - 527KB) Draft Guidance 11/05/13
Clinical / Antimicrobial Complicated Intra-Abdominal Infections: Developing Drugs for Treatment (PDF - 304KB) Final Guidance 02/09/15
Clinical /Antimicrobial Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance (PDF - 167KB) Draft Guidance 02/27/14
Clinical / Antimicrobial Uncomplicated Gonorrhea: Developing Drugs for Treatment (PDF - 222KB) Final Guidance 08/17/15
Clinical/Antimicrobial Vaginal Microbicides:Development for the Prevention of HIV Infection PDF (PDF - 352KB) Final Guidance 11/18/14

Page Last Updated: 05/03/2016
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