title: Regulatory Forum Opinion Piece: Review of FDA Draft Guidance Testicular Toxicity-Evaluation during Drug Development Guidance for Industry.
abstract: In July 2015, the U.S. Food and Drug Administration (FDA) posted a new draft guidance entitled "Testicular Toxicity: Evaluation during Drug Development Guidance for Industry," with a 90-day public comment period. As the nonclinical assessment of testicular toxicity often relies on the expert interpretation of pathology affecting the male reproductive tract, this draft guidance is considered directly relevant to the toxicologic pathology community. Therefore, a working group was formed through the Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathologists (STPs) to provide a detailed review of the draft guidance. Specific comments on the guidance were submitted to the FDA by the STP. The draft guidance and all comments received are currently under review with the FDA. This commentary provides a summary of the components of the draft guidance and the comments submitted by the STP with acknowledgment of different perspectives reflected in comments from other respondents.
authors.affiliation: The Dow Chemical Company, Midland, Michigan, USA rhukkanen@dow.com.
authors.forename: Renee R
authors.initials: RR
authors.lastname: Hukkanen
authors.affiliation: Genentech, South San Francisco, California, USA.
authors.forename: Wendy G
authors.initials: WG
authors.lastname: Halpern
authors.affiliation: MPI Research, Mattawan, Michigan, USA.
authors.forename: Justin D
authors.initials: JD
authors.lastname: Vidal
mesh_terms: D000818:Animals; D017277:Drug Approval; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D013737:Testis / Q000187:drug effects*; D018675:Toxicity Tests; D014481:United States; D014486:United States Food and Drug Administration
keywords: safety assessment; testes; toxicity