Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues

May 31, 2022

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

Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.

FDA North America Computer generated rendering molecules, cells, and DNA structures.

June 16, 2022

Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...

Read the Full Article
FDA North America Illustration of a magnifying glass enlarging a checklist.

July 8, 2022

CVM GFI #245 - Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

July 2022 The purpose of this guidance is to help animal food facilities develop a food safety plan that complies with FDA’s Hazard Analysis and Risk-Based Preventive Controls requirements....

Read the Full Article
FDA North America Examples of chemical compounds.

June 23, 2022

FDA revises 2013 guidance for Non-Penicillin Beta-Lactam Drugs

Draft Guidance June 2022 FDA is announcing the availability of a draft guidance titled, "Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination." This guidance revises...

Read the Full Article