Oncology Pharmaceuticals Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry


The purpose of this guidance is to assist sponsors in reproductive toxicity assessments (mainly of embryo-fetal development (EFD)) for anticancer pharmaceuticals and to provide recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo/fetus. The following concepts are  discussed in this guidance:
  Evaluation of EFD toxicity for various types of pharmaceuticals and when such studies  are not needed
 Evaluation of EFD toxicity for pharmaceuticals intended for specific populations
 Use of nonclinical information such as results of genotoxicity and general toxicity studies in assessing the need for a dedicated EFD study
  Labeling recommendations concerning EFD studies and the potential risk for adverse developmental outcomes in humans (Pregnancy subsection of labeling) and  recommendations for contraception in male and female patients to minimize risk to a developing embryo/fetus (Females and Males of Reproductive Potential subsection of labeling)
For more details refer below link;

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM577552.pdf



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