approval time
approval time
An FDA (US) term for the time elapsed between the first New Drug Application (NDA) submission to NDA approval, which is the sum of FDA review time for the first submission of an NDA to the Agency, plus any subsequent time during which a pharmaceutical sponsor addresses deficiencies in the NDA and resubmits the application, plus subsequent FDA review time.Examples Approval actions; changes in labelling, route of administration, and patient population for a drug product.