Discussion of FDA Industry Guidelines for Developing Gonadotropin-Releasing Hormone Analogues for Advanced Prostate Cancer

E. David Crawford, MD, and Celestia Higano, MD, presented “Discussion of FDA Industry Guidelines for Developing Gonadotropin-Releasing Hormone Analogues for Advanced Prostate Cancer.” for the Grand Rounds in Urology audience in August, 2019.

How to cite: Crawford, David E. and Higano, Celestia. “Discussion of FDA Industry Guidelines for Developing Gonadotropin-Releasing Hormone Analogues for Advanced Prostate Cancer” August, 2019. Accessed Nov 2019. https://grandroundsinurology.com/discussion-of-fda-industry-guidelines-for-developing-gonadotropin-releasing-hormone-analogues-for-advanced-prostate-cancer​/

Discussion of FDA Industry Guidelines for Developing Gonadotropin-Releasing Hormone Analogues for Advanced Prostate Cancer – Summary:

E. David Crawford, MD, and Celestia Higano, MD, discuss the United States Food and Drug Administration’s  announcement of the availability of a draft guidance for industry document entitled “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.” This draft guidance describes the FDA’s current recommendations regarding the overall development program and clinical trial designs for developing gonadotropin-releasing hormone (GnRH) analogues to treat advanced prostate cancer.

Additional information on the FDA’s draft guidance is available at: FDA Draft Industry Guidance for Developing Gonadotropin-Releasing Hormone Analogues for Treating Advanced Prostate Cancer