17 de julho de 2019

FDA NEWS: FDA Announces Draft Guidance For Developing GnRH Analogues for Prostate Cancer

From: www.fda.gov

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled, “Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues.” This draft guidance provides recommendations for drug development programs to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer. Prostate cancer is one of the most common forms of cancer in American men. GnRH analogues are the primary treatment for patients with prostate cancer. Therefore, it is important to ensure industry has the most current information available for development of GnRH analogues.

The draft guidance outlines standardizing trial design including information regarding patient population, endpoints, chemistry, manufacturing and statistical considerations. The guidance also addresses the regulatory requirements for approval of GnRH analogues.

The FDA seeks comments and suggestions on this draft guidance. For more information, please refer to the guidance document and the Federal Register Notice.