Glossary

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  • 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. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA).  By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

  • Review

    A 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 FDA drug application reviewers.  A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.

  • Review Classification

    The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and prioritizing their review. (List of Review Classifications and their meanings2)

  • Route

    A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the CDER Data Standards Manual3.