Glossary

Generic Drug

February 27, 2012

A drug product sold under the provisions of Section 505(j) of the Federal Food, Drug and Cosmetic Act. The Abbreviated New Drug Application (ANDA) was enabled through the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman). The ANDA must contain (1) information to show conditions of the proposed generic drug's labeling have been previously approved for the "reference listed drug" (RLD), (2) that the generic drug is pharmaceutically equivalent to the RLD (same active ingredient, route of administration, dosage form and strength), (3) that the generic drug is bioequivalent to the RLD, (4) the generic drug must have the same labeling as the RLD, and (5) the generic drug must be manufactured in compliance with cGMPs. Finally, with regard to patents, the sponsor of a generic drug application must certify to the FDA that (I) information on any patents were not filed by the NDA holder with FDA, (II) relevant patent(s) have expired, (III) relevant patent(s) will expire on some future date, or (IV) relevant patent(s) are invalid or would not be infringed by the manufacture of a generic version.
  • Packaging Equipment Technology Preview

    Packaging Equipment Technology Preview

    February 15, 2017
    Today’s complex drug products present challenges; the latest equipment capabilities help overcome them

  • The Good, the Bad, and the Donald

    The Good, the Bad, and the Donald

    January 31, 2017
    Orphan drugs, CMO continuous manufacturing and developing world sales offer biggest revenue opportunities

  • Predictive Analytics and the Future of RBM

    Rajneesh Patil, Senior Director, RBM and Analytics, QuintilesIMS||January 23, 2017
    How advances in Risk-Based Monitoring will enable a more proactive approach to identify and mitigate potential risks