Comment from The PPD clinical research business of Thermo Fisher Scientific
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Summary: Thermo Fisher Scientific (PPD Development, L.P.) supports the Expedited Investigational New Drug Pilot Program, providing detailed recommendations on QRI qualifications, regulatory processes, and drug eligibility. They advocate for a flexible approach to QRI requirements, emphasizing demonstrated regulatory capabilities and integrated drug development strategies over mandatory ownership of all infrastructure.
The PPD clinical research business of Thermo Fisher Scientific is pleased to provide our public response to the Food and Drug Administration's Expedited Investigational New Drug Pilot Program Request for Information [Docket No. FDA-2026-N-4699].