Federal Register Notice: FDA is making available a draft guidance for industry entitled Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity. It is intended to supplement CDER’s 1998 guidance for industry, Environmental Assessment of Human Drug and Biologics Applications by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid pathway activity (E, A, or T activity) in environmental organisms. It is also intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for NDAs and certain NDA 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. To view this notice, click here.