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# Gonadotropin-Releasing Hormone Analogues Guidance
- URL: https://www.fdaweb.com/gonadotropin-releasing-hormone-analogues-guidance/
- Published: 2019-07-17T12:00:00.000Z
- Updated: 2026-09-15T01:38:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144552

FDA has issued a draft guidance, *Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues*, with the agency’s current recommendations for an overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone analogues for treating advanced prostate cancer. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-prostate-cancer-developing-gonadotropin-releasing-hormone-analogues-guidance-industry?ref=fdaweb.com) says that new drug applications for the analogues typically rely, in part, on an agency finding of safety and/or effectiveness for a previously approved analogue. They are submitted through the 505(b)(2) pathway. The guidance addresses the current regulatory requirements for approval of the agents and the use of a standardized approach to trial design.

Contents of the guidance are Introduction, Background, Development Program (product development, nonclinical development, phase 3 efficacy trial considerations, and labeling considerations), and Appendix.