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FDA | FDA Centennial
Red box, Discovery. Arrow pointing to red box, Method Development. Arrow pointing to red box, Study Protocol Proposal. Arrow pointing to green box, FDA Protocol Review. Another arrow points back to previous red box, Study Protocol Proposal.
Arrow from green box, FDA Protocol Review points down to red box, Dose-Ranging Study. Arrow pointing to red box, Qualification Study. Arrow pointing to red box, Qualification Study Report. Arrow pointing to green box, FDA Report Review (box includes a yellow diamond shape with the words Probable Valid Biomarker) and another arrow pointing to olive box, External Review (optional) and yellow diamond shape, Probable Valid Biomarker.
Green box, FDA Report Review, has
an arrow pointing back to red box, Qualification
Study Report and an arrow pointing to olive box, Expert Panel (if needed).
Arrow pointing to olive box, External Review (optional) and yellow diamond
shape, Probable Valid Biomarker.
Boxes Study Protocol Proposal, FDA Protocol Review, Dose-Ranging Study, and Qualification Study are in a larger blue box with the words Determine Relevance for Clinical Safety, Pharm/Tox, Genomics, Other areas as needed.