FDA-TRACK: Center for Drug Evaluation and Research - Pre-Approval Safety Review - Generics Dashboard
Policy and Science
Development
Pre-Approval Safety
Review
Post-Approval Safety
Monitoring
FDA’s Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. CDER also regulates other non-medicines that are considered to be drugs like fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens. CDER protects and advances public health by ensuring safe and effective drugs are available to improve the health of people in the United States.
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.
Download Generics Dataset PDF / Print Version
Footnotes:
- Data collection began with FY 16 submissions.>
- ANDA submitted figures are for ANDA originals submitted or ANDA responses to a Refuse to Receive (RTR).
- PAS submitted figures are for initial PAS’s submitted or responses to a Refuse to Receive (RTR).
- First cycle is the time between the receipt of, and the action on, the submission that gets acknowledged for filing. The first cycle occurs before an applicant responds to any deficiencies outlined in a complete response letter.
- First generic is any received ANDA: (1) that is a first-to-file ANDA eligible for 180-day exclusivity or for which there are no blocking patents or exclusivities, and; (2) for which there is no previously approved ANDA for the drug product.
- Post-CR teleconferences are a teleconference following a complete response letter where the applicant’s goal is to gain an understanding of specific deficiencies and expectations for their resolution. A letter may substitute for a teleconference.
- First cycle performance includes applications that had a goal date within the quarter. As the goal date has passed, any application pending an action has missed the goal.
- First cycle performance adjusted for imminent approval or tentative approval, in addition to actions taken before the goal date, counts overdue first cycle approvals and tentative approvals as met if the goal was missed by 60 days or less. The rationale for this is that FDA will intentionally refrain from taking a complete response action and miss a goal if approval or tentative approval is imminent. The percentage shown may not be final as applications pending an action may still get an imminent approval or tentative approval.
- The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. The data presented in the visualizations above can be accessed by clicking on the link labeled "Download Generics Dataset" located right below the visualizations.
- Data contained in the dashboard is not final, but accurate at the time of posting.