1. Home
  2. About FDA
  3. Performance Data
  4. FDA-TRACK: Agency-wide Program Performance
  5. FDA-TRACK: Generic Drugs Program Monthly and Quarterly Activities Dashboard
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Generic Drugs Program Monthly and Quarterly Activities Dashboard

New!

The Generic Drugs Program Monthly and Quarterly Activities Report has been integrated into FDA-TRACK, FDA's agency-wide performance management program. This transition supports broader efforts to consolidate and streamline performance reporting across the agency. Monthly data will now be presented through interactive visualizations, making it easier to explore and analyze program performance.

Subscribe to FDA-TRACK Updates

FDA-TRACK: CDER
FDA-TRACK: Biologics
FDA-TRACK Home Page

GDUFA was enacted on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), and was most recently reauthorized on September 30, 2022, extending the program through September 30, 2027. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications.

These dashboards report FDA's monthly actions on Abbreviated New Drug Applications (ANDAs) and related generic drug submissions, as well as quarterly approval time metrics under the Generic Drug User Fee Amendments (GDUFA) program. Data are updated regularly throughout each fiscal year and reflect current counts at the time of posting; figures may be revised as application statuses are updated.

Actions

 
 

Submissions

 
 

Approval Times

Download Monthly and Quarterly Activities Dataset

 

Note

Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates. These numbers are not intended for Congressional reporting purposes. Indented metrics are included in the count of the non-indented metric above it.

Abbreviations

PAS = Prior Approval Supplements
DMF = Drug Master File
CRL = Complete Response Letter
CBE = Changes Being Effected
PSG = Product-Specific Guidances

Footnotes

  1. + Pending ANDAs Awaiting FDA Action are applications currently being reviewed by FDA.
  2. ++ ANDAs Awaiting FDA Action and ANDAs Awaiting Applicant Action represent a snapshot in time for the status of distinct original ANDAs. Many of these applications have been reviewed and found “not approvable” in a previous cycle and have been resubmitted by the applicant for another cycle of review and assessment. These metrics are calculated at the end of the month or just thereafter.
  3. +++ ANDAs Awaiting Applicant TA are applications that have a status of ‘TA’ or Tentative Approval. If a generic drug product is ready for approval but cannot be approved due to a patent or exclusivity related to the reference listed drug product, FDA issues a tentative approval letter to the applicant, and the tentative approval letter details the basis for the tentative approval. A tentative approval does not allow the applicant to market the generic drug product. The Federal Food, Drug, and Cosmetic Act (FD&C Act) delays final approval of the generic drug product until all patent or exclusivity issues have been resolved or, in some cases, until a 30-month stay associated with patent litigation has expired.
  4. ++++ Applications Awaiting Applicant Action are applications that have a status of ‘CR’ or Complete Response. These applications have been reviewed by FDA and the data submitted are inadequate to support approval.
  5. * Original Receipts are reported as raw receipts (versus filed receipts).
  6. ** PAS Supplements do not include REMS PAS supplements.
  7. *** Controls count only those requests deemed appropriate for a control.
  8. ^ Mean/ Median AP/TA calculated as the difference between the first full approval (AP) date or the first Tentative Approval (TA) date and the date the original application was accepted for filing divided by the average number of days per month (30.4375). The unit for each of these metrics is months.

Previous Monthly Reports

Previous Quarterly Reports

 

Back to Top