FDA《人用药品与生物制品申请的环境评估》行业指南（1998年7月定稿，Docket No. FDA-1998-D-0278）
Environmental Assessment of Human Drug and Biologics Applications
FDA发布《人用药品与生物制品申请的环境评估》行业指南定稿，Docket No. FDA-1998-D-0278，由CDER与CBER发布。依据NEPA及21 CFR part 25，特定NDA、简化申请、生物制品上市申请及其补充、IND等须提交环境评估，除非符合类别豁免。
GUIDANCE DOCUMENT
Environmental Assessment of Human Drug and Biologics Applications Guidance for Industry July 1998
Final
- Docket Number:
- FDA-1998-D-0278
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses. The Food and Drug Administration (FDA) is required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process. FDA's regulations in 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions (see 21 CFR 25.20), unless the action qualifies for categorical exclusion.
Submit Comments
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:
Dockets Management
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-1998-D-0278.
来源：FDA Pharmaceutical Quality Documents · fda.gov