Biomaterial Database

The path to new FDA guidelines for clinical evaluation of anti-infective drugs. 1991

D N Gilbert, and T R Beam, and C M Kunin

Providence Medical Center, Portland, Oregon 97213.

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.

UI	MeSH Term	Description	Entries
D002986	Clinical Trials as Topic	Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.	Clinical Trial as Topic
D003141	Communicable Diseases	An illness caused by an infectious agent or its toxins that occurs through the direct or indirect transmission of the infectious agent or its products from an infected individual or via an animal, vector or the inanimate environment to a susceptible animal or human host.	Infectious Diseases,Communicable Disease,Disease, Communicable,Disease, Infectious,Diseases, Communicable,Diseases, Infectious,Infectious Disease
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000890	Anti-Infective Agents	Substances that prevent infectious agents or organisms from spreading or kill infectious agents in order to prevent the spread of infection.	Anti-Infective Agent,Anti-Microbial Agent,Antimicrobial Agent,Microbicide,Microbicides,Anti-Microbial Agents,Antiinfective Agents,Antimicrobial Agents,Agent, Anti-Infective,Agent, Anti-Microbial,Agent, Antimicrobial,Agents, Anti-Infective,Agents, Anti-Microbial,Agents, Antiinfective,Agents, Antimicrobial,Anti Infective Agent,Anti Infective Agents,Anti Microbial Agent,Anti Microbial Agents
D012955	Societies, Medical	Societies whose membership is limited to physicians.	Medical Societies,Medical Society,Society, Medical
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration