Reference Listed Drug (RLD)A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent.
Respiratory DepressionSlowing of respiration (breathing) that results in the reduced availability of oxygen to vital organs.
ReviewA review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by…
Review ClassificationThe NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and…
routeA route of administration is a way of administering a drug to a site in a patient.