Reference Listed Drug (RLD)

February 27, 2012

An FDA-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 RLD in its ANDA. By designating a single RLD as the standard to which all generic versions must be shown to be bioequivalent, the FDA intends to avoid possible significant variations among generic drugs and brand counterparts.
blog comments powered by Disqus
  • The Role of Value in Drug Pricing

    The Role of Value in Drug Pricing

    Keren Shani, Ryan Million, Trinity Partners ||October 11, 2016
    Exploring the trend of using frameworks and models to evaluate the value of a drug

  • CRO-Sponsor Partnerships

    CRO-Sponsor Partnerships

    Craig Morgan, Brand Development Director, goBalto Inc.||October 11, 2016
    10 tips for enabling better CRO and sponsor collaborations

  • The Human Parts of Mouse Models

    The Human Parts of Mouse Models

    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company ||October 11, 2016
    The PDX model system has come back into focus