Biotech-backed nonprofit joins with FDA to standardize process for submitting in vitro pharmacology data
The biotech-backed nonprofit Pistoia Alliance is putting together a new working group that will include liaisons from the FDA’s Center for Drug Evaluation and Research to develop a standardized and shared template for in vitro pharmacology (IVP) data in regulatory submissions.
The working group, which also will include CRO and tech supplier reps, is meant to help consistently align IVP data submissions to the FDA before sponsors take their investigational drugs into human testing. Current regulations require sponsors to provide a tox summary of a developing drug in animals and in vitro, although the particular studies that need to be run depend on the compound and the phase of investigation, the FDA says.
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