FDA-TRACK is FDA's agency-wide performance management program that monitors, analyzes and reports key performance data and projects for FDA's program offices and cross-cutting initiatives.
Generic drugs are important options that allow greater access to health care for all Americans. Availability of generic drugs drives price competition and has helped millions of Americans obtain access to less costly but still safe and effective drug therapies. Generic drugs are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Through oversight of laboratory and other scientific testing and research that demonstrates “bioequivalence” between products, CDER works to ensure that generic drugs offer the same therapeutic value to patients as their brand name counterparts.
Data contained in the dashboard is not final, but accurate at the time of posting; refer to the GDUFA Performance Reports to Congress for official data.
For a complete list of CDER measures and their relevant FDA-TRACK dashboard, refer to the FDA-TRACK CDER Index.