Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues

Guidance Document

Center for Drug Evaluation and Research

This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.

The recommendations in section III.C., Registrational Trial Considerations, apply to drug product development programs for GnRH analogues in advanced prostate cancer for all dosage forms and routes of administration (e.g., tablets, capsules, injectable suspensions, injectable emulsions, subcutaneous implants). Other sections apply only to extended-release injectable dosage forms.

Download the Final Guidance Document

Final Level 1 Guidance

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