IND, Clinical Trail for small-molecule and biologics, NDA, Marketing Submission for small-molecule drugs, Class 1 MD, Mostly Exempt or 510 (k), Class 2 MD, 510 (k) for substantially equivalent MD, Class 3 MD, PreMarkter Approval, Class 1 & 2 Noval MD, De Novo, HDE, For rare disease or condition affecting fewer than 8000 individual per year in US, Office of combination products, Confirm which is the lead and the respective pathway

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