FDA Adopts ICH Guideline on Nonclinical Evaluation for Anticancer Drugs

Regulatory NewsRegulatory News
| 15 June 2018 | By Michael Mezher 

With the publication of a final guidance on Friday, the US Food and Drug Administration (FDA) has adopted the International Council for Harmonization's (ICH) questions and answers guideline on the nonclinical evaluation of drugs intended to treat cancer.
The final guidance comes less than two months after ICH advanced the document for international implementation in late April.
The guideline, which contains 41 questions and answers aimed at providing additional clarity about oncology drug development, is meant to be read alongside ICH's 2009 guideline S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.
In 2014, ICH formed a working group to develop the questions and answers guideline after finding that many of the aspects covered by ICH S9 were "open to broad and divergent interpretation by both regulatory authorities and industry."
In addition to providing greater clarity on anticancer drug development, FDA says the questions and answers guideline will help with progress toward the 3Rs: reduction, refinement and replacement in the use of animals in drug development.
FDA also says the guideline has been updated since the draft questions and answers were first circulated to provide greater clarity and delete certain questions "due to a lack of harmonization.”
In particular, FDA says the final version of the guideline provides greater clarity on its scope, additional recommendations on developing antibody-drug conjugates and the need for recovery animals in general toxicology studies.
Guidance, Federal Register Notice


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