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New PDUFA VII Pilot Program for SMC Submission Packages

If you have ever supported Chemistry, Manufacturing, and Controls (CMC) submission packages for a product that has accelerated clinical development timelines, you know the challenges 😅! So the news that PDUFA VII has a pilot program for CBER- and CDER-regulated products to facilitate CMC readiness is welcome news indeed!!


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Troubleshooting Bioassays

Sharing an abstract of work together with Anthos Therapeutics and Accurant Biotech, Inc (https://www.accurantbiotech.com) of a new anti-drug antibody assay format that successfully addressed a false p

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