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Event Title
Substitutability of Generic Drugs: Perceptions and Reality

FDA-Johns Hopkins University CERSI Co-sponsored Workshop

November 18, 2016
Goals and Objectives: 

FDA is entrusted to ensure all medications entering the U.S. market are safe and effective, including generic drugs. Generic drugs account for 88% of prescriptions in the United States. In light of significant contributions of generic drugs to public health,it is important that FDA develop a range of tools to monitor marketed generic drugs to ensure they have the same safety and efficacy profiles as their Reference Listed Drug (RLD).

This workshop:

  • Discussed current progress on generic drug surveillance method development, generic substitution study outcomes, and surveys about generic drugs
  • Built confidence in generic drugs by demonstrating FDA’s commitment to monitoring generic drugs in the postmarket setting and presenting evidence to confirm equivalency
  • Provided timely communication of the results of postmarket research related to generic drugs
  • Identified future research needs in postmarket surveillance of generic drugs.

For information on the agenda, see the Johns Hopkins University CERSI Website. disclaimer icon.


Food and Drug Administration
White Oak Campus
The Great Room (1503A)
10903 New Hampshire Ave.
Silver Spring, MD 20993 


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