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Guidance Issuing OfficeCenter for Veterinary Medicine
The purpose of this document is to provide guidance for the use of a single set of environmental fate and toxicity data to be used by applicants/sponsors to obtain marketing approval in all VICH regions for those veterinary medicinal products (VMPs) identified as recommending data during the Phase I process. It also aims to be a major contribution towards the common use of study methods used to generate these data.
It needs to be kept in mind that guidances should not consist of rigid stipulations, but should make clear recommendations on the minimum information needed. By their nature, guidances address most, but not all possible eventualities. Each case has to be considered on its merits, and if in a particular circumstance an alternative approach, for example use of data published in the literature, is deemed more fitting, a reasoned argument for the deviation should be prepared and discussed with appropriate regulatory authorities before work is initiated.
Besides serving as a common basis for the Environmental Impact Assessment (EIA), this document provides recommendations to protect the environment. The field of ecotoxicology is a complex science and gaps in data and knowledge exist. Notwithstanding these limitations, the Phase II recommendations should be based on science and strive for objectivity. The maximum amount of information should be extracted from each study to achieve an understanding of the potential for a given VMP to affect the environment.
An important factor in the use of the guidance contained herein is professional judgement. Expertise in the appropriate scientific disciplines is a valuable prerequisite for designing an EIA program for VMPs. Such expertise is important in evaluating the relevance of available data, for predicting environmental exposures, for identifying the recommended studies, and interpreting exposures relative to endpoint values obtained in such studies.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2004-D-0273.