The FDA, along with GSK, MilliporeSigma, and the University of Delaware, will:
Reduce the use of animals for adventitious agent testing
Streamline and standardize bioinformatic analysis pipelines
Decrease cost and time required for adventitious virus testing, helping to facilitate more rapid product development
Assist regulatory agencies with decision-making and policy development regarding the use of NGS for replacing the in vivo animal assays and for replacing or supplementing the in vitro assays currently used for virus testing
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Federal Stakeholder: Food and Drug Administration