Environmental Assessment: Questions and Answers Regarding Drugs With Oestrogenic, Androgenic, or Thyroid Activity; Draft Guidance for Industry; Availability

The United States Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Environmental Assessment: Questions and Answers Regarding Drugs With Oestrogenic, Androgenic, or Thyroid Activity.” This guidance is intended to supplement CDER’s guidance for industry on “Environmental Assessment of Human Drug and Biologics Applications,” issued July 1998, by addressing specific considerations for drugs that have potential oestrogenic, androgenic, or thyroid pathway activity (E, A, or T activity) in environmental organisms. It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for new drug applications (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. Although you can comment on any guidance at any time (see21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by 29 June 2015.

U.S Federal Register, 29 April 2015 ;http://www.gpoaccess.gov/fr ;