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GUIDANCE DOCUMENT

Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry Clinical/Medical May 2022

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2019-D-2808
Issued by:
Guidance Issuing Office
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.

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All written comments should be identified with this document's docket number: FDA-2019-D-2808.

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