Dr Richard Lipscombe gave the Opening Keynote Address. Title: “Plasma Biomarkers for Diabesity:...
Proteomics International files US FDA 513(g) regulatory submission
513(g) application will allow Proteomics International to determine the best product classification and FDA regulatory path for PromarkerD.
Application replaces pre-submission package filed in February, after the FDA limited this pathway to urgent applications only due to the COVID-19 pandemic.
Projected timelines to a full FDA application and subsequent commercialisation remain unaffected.