Draft Guidance Outlines ICH Standards for Genomic Sampling in Clinical Trials

In conjunction with an ICH working group, the FDA blessed a guidance originally published by ICH in December 2015 that encourages clinical trial sponsors to practice genomic sampling in clinical development.

As one of the ICH regions, the FDA is releasing the document as part of a two-month public consultation. It is expected to be finalized by mid-2017.

Read the guidance here: www.fdanews.com/06-02-16-GenomicSamplingGuidance.pdf.