GUIDANCE DOCUMENT
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry Draft Clinical/Medical July 2019
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-2808
- Issued by:
-
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. In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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All written comments should be identified with this document's docket number: FDA-2019-D-2808.