The FDA is changing its reporting requirements for GDUFA III.  It appears from the changes that some information may be more difficult to gather and will be removed from the monthly Generic Drugs Program Activities Report we have all come to love and will be moved to either quarterly or annual reports.

The monthly report that will continue to include:

  1. Number of ANDAs and amendments, CBE supplements, and PASs submitted in the reporting month delineated by type of submission;
  2. Number of ANDAs and PASs FDA refused-for-receipt in the reporting month;
  3. Number of actions taken in the reporting month delineated by the type of action. For purposes of the metrics, actions shall include final approvals, tentative approvals, CRLs, IRs, and DRLs (or other such nomenclature as FDA determines to reflect the concepts of an information request or CRL);
  4. Number of finalized DMF Completeness Assessments in the reporting month;
  5. Number of DMF fees paid in the reporting month (note this is a new addition to the monthly report);
  6. Number of first-cycle approvals and tentative approvals in the reporting month.

Items removed from the monthly report include number of ANDAs and Supplements withdrawn each month and the number of controlled correspondences (CCs) received each month, with the CCs additionally broken down by complex and non-complex CCs submitted which will now appear in a quarterly report along with the following five additional metrics:

  1. Number of ANDAs awaiting applicant action;
  2. Number of ANDAs awaiting FDA action;
  3. Mean and median approval and tentative approval times for the quarterly action cohort;
  4. Number of original ANDAs for Complex Generic Products submitted;
  5. Number of requests for reclassification of a Facility-Based Major CRL Amendment received, and number of requests granted and denied.

The Fiscal year report performance Report Metrics include 21 different metrics, too numerous to list here but can be viewed (starting on page 42 of the commitment letter) (here).

Last but not least, the FDA will post the following metrics on its webpage annually:

  1. The number of requests for review of a DMF prior to ANDA or PAS submission, as described in sections VI(E)(1) and VI(E)(2) [ of the commitment letter], the number granted, and the number completed;
  2. Number of priority and non-priority “off-cycle” solicited DMF amendments reviewed, as described in section VI(F); and
  3. Number of original approvals taken that are Imminent Actions

Lots of metrics and lots of numbers. Hopefully this information will make the OGD review process that much more transparent. We only have the next 6 years (one last year of GDUFA II and the 5 new years of GDUFA III) to figure that out!