Developing New Regulatory Approaches to Antimicrobial Safety
| Autor: | L. Tollefson |
|---|---|
| Rok vydání: | 2004 |
| Předmět: |
Drug
Drug Utilization medicine.medical_specialty Meat Veterinary Drugs Health Planning Guidelines media_common.quotation_subject Risk Assessment Antibiotic resistance Drug Resistance Bacterial Animals Humans Medicine Intensive care medicine media_common United States Food and Drug Administration business.industry Public health General Medicine Antimicrobial United States Anti-Bacterial Agents Biotechnology Drug development business Risk assessment |
| Zdroj: | Journal of Veterinary Medicine Series B. 51:415-418 |
| ISSN: | 1439-0450 0931-1793 |
| Popis: | Resistance to antimicrobial agents is of concern to public health officials worldwide. In industrialized countries, a significant source of antimicrobial-resistant food-borne infections in humans is the acquisition of resistant bacteria originating from animals. The US Food and Drug Administration (FDA) is committed to resolving the public health impact arising from the use of antimicrobial drugs in food-producing animals. The FDAs goal is to ensure that significant human antimicrobial therapies are not compromised or lost while providing for the safe use of antimicrobials in food animals. Recently the FDA published a guidance document titled 'Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern' (US Food and Drug Administration, Center for Veterinary Medicine, 2003). This document outlines a pathway drug sponsors can use to address concerns about antimicrobial resistance prior to approval of their drug. The process uses a qualitative risk assessment approach to assess the potential of the intended use of a product to develop resistance in bacteria that may harm humans. The level of risk determines the level of risk management that is required for the drug to be used. The Food and Drug Administration (FDA) always has the option of not approving a drug if the risk of a public health consequence is too high. |
| Databáze: | OpenAIRE |
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