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Education

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.
Agenda:

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

Location:

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

Recordings