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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-2808.