The Path to New FDA Guidelines for Clinical Evaluation of Anti-Infective Drugs

This article describes the current collaborative effort of the U.S. Food and Drug Administration and the Infectious Diseases Society of America to generate new general and disease/organism-specific guidelines for the evaluation of anti-infective agents. The description includes examples of proposed...

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Bibliographic Details
Published in:Reviews of infectious diseases 1991-09, Vol.13, p.S890-S894
Main Authors: David N. Gilbert, Thomas R. Beam, Jr, Kunin, Calvin M.
Format: Article
Language:English
Subjects:
Anti-Infective Agents - therapeutic use
Antibacterials
Antimicrobials
Biological and medical sciences
Clinical trials
Clinical Trials as Topic - standards
Communicable Diseases
Diplomatic protocol
Dosage
General aspects
Humans
Infections
Infectious diseases
Medical sciences
Medication administration
Pharmaceutical industry
Physicians
Session III: Health Care Policy and Practice
Societies, Medical
United States
United States Food and Drug Administration
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Summary:This article describes the current collaborative effort of the U.S. Food and Drug Administration and the Infectious Diseases Society of America to generate new general and disease/organism-specific guidelines for the evaluation of anti-infective agents. The description includes examples of proposed changes from draft documents. If approved and implemented, the envisioned changes should enable investigators and sponsors to improve the quality of clinical trials of anti-infective drugs. The ultimate goal is to provide physicians with the best information about new drugs and thus to enhance the care of patients with infectious diseases.
ISSN:0162-0886