Japanese Regulators Accept Critical Path's Biomarkers for Drug Toxicity Tests | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The Critical Path Institute today said that the Japanese Pharmaceuticals and Medical Devices Agency has accepted its seven-biomarker panel for use in detecting drug-induced kidney injury.

The acceptance, the first ever regulatory biomarker qualification decision by PMDA, means data generated using the panel can be submitted to the agency as part of the drug approval process in Japan, Critical Path said in a statement.

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