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Regulatory Focus™ > News Articles > 3 > FDA Finalizes ICH’s Genomic Sampling Guidance

FDA Finalizes ICH’s Genomic Sampling Guidance

Posted 02 March 2018 | By Ana Mulero 

FDA Finalizes ICH’s Genomic Sampling Guidance

Forging ahead with greater regulatory harmonization, the US Food and Drug Administration (FDA) adopted the International Conference for Harmonization (ICH) guideline on genomic sampling.

The genomic sampling and data management guidance – issued on Thursday – builds on the momentum gained in recent years for the greater use of biomarkers in the medical product development process.

“Awareness of, and interest in, genomic data obtained from clinical studies are growing,” the guidance notes. “The generation and interpretation of genomic data, both within and across clinical studies and drug development programs, allow for a better understanding of pharmacological and pathological mechanisms and enable the identification of new drug targets.”

Recommendations outlined in the new guidance address general principles for collecting, processing, transporting, storing, and dispositioning genomic samples or data, as well the technical aspects that apply to any genomic research that uses materials derived from humans.

The guidance also came into effect for device and drug makers in the EU this week, according to a notice from the European Medicines Agency. Japan’s Pharmaceuticals and Medical Device Agency adopted it on 18 January.

FDA also finalizedthe ICH good clinical practices guidance on Wednesday, encouraging industry to use “more efficient approaches to clinical trial design, conduct, oversight, recording and reporting,” among other objectives.



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