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# Guidance on Environmental Assessment on Certain Drugs
- URL: https://www.fdaweb.com/guidance-on-environmental-assessment-on-certain-drugs/
- Published: 2016-03-07T12:00:00.000Z
- Updated: 2026-09-15T02:41:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134988

*Federal Register* Notice: FDA is making available a guidance for industry entitled *Environmental Assessment: Questions and Answers Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity.* It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) 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. To download this guidance, click [here.](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM444658.pdf?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-07/pdf/2016-04964.pdf?ref=fdaweb.com)