Substitutability of Generic Drugs: Perceptions and Reality

Education

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. .

Location:

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

Recordings

• Session 1: https://collaboration.fda.gov/p56t5gyshf7/
• Session 2: https://collaboration.fda.gov/p3655rrsm0h/
• Session 3: https://collaboration.fda.gov/p40zd0pks4v/
• Session 4: https://collaboration.fda.gov/p82bcf3qb78/