FDA发布具有雌激素、雄激素或甲状腺活性药物环境评估问答最终指南
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity
FDA发布最终指南，补充1998年环境评估指南，针对具有潜在雌激素、雄激素或甲状腺激素通路活性的药物。该指南由CDER发布，用于帮助此类药物申办者判断是否应为药品申请及某些补充申请提交环境评估，并说明提交分类排除主张代替环境评估时应包含哪些信息。意见可通过案卷编号FDA-2013-S-0610提交。
GUIDANCE DOCUMENT
Final
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to supplement FDA’s guidance for industry on Environmental Assessment of Human Drug and Biologics Applications, issued July 1998 (the EA Guidance), by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid hormone pathway activity (E, A, or T activity) in the environment. It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EAs) for drug applications and certain supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov