Issue Date: March 4, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity
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.
Download the Guidance Document
