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GUIDANCE DOCUMENT

Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry Guidance for Industry May 2019

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2017-D-2165
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in evaluating reproductive toxicity (mainly for effects on embryo-fetal development (EFD)) for oncology pharmaceuticals and to provide recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus. This guidance is intended to facilitate the development of oncology pharmaceuticals while avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles. The following concepts are discussed in this guidance:

• Evaluation of EFD toxicity for various types of pharmaceuticals • Evaluation of EFD toxicity for pharmaceuticals intended for specific populations

` • Use of available information, such as the results of genotoxicity and general toxicity studies, knowledge of target biology, and available data on genetically modified animals in assessing the need for a dedicated EFD study

 • Labeling recommendations for duration of contraception in male and female patients to minimize risk to a developing embryo or fetus (Females and Males of Reproductive Potential subsection of labeling)

Submit Comments

Submit Comments Online

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:

Dockets Management
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-2017-D-2165.

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