GDUFA requires that human generic drug facilities, and certain sites and organizations identified in a generic drug submission, provide identification information annually to FDA. This information will assist in constructing an accurate inventory of facilities, sites and organizations involved in the manufacture of generic drugs, setting annual facility fee amounts, and targeting inspections.
The documents listed below are intended to help organizations ascertain if they need to self-identify with the FDA, determine what information they are required to submit, and familiarize themselves with the means and format for submitting the required information.
Self-identification information must be submitted by November 30, 2012.
This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API)drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA) or an amendment or prior approval supplement (PAS) to an ANDA (generic drug submissions). The guidance explains that, beginning October 1, 2012, under GDUFA:
- DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application, and
- Type II API DMFs must undergo an FDA initial completeness assessment.
The guidance makes recommendations about the information that should be included in the DMF to facilitate an initial completeness assessment (CA). The guidance does not apply to new drug applications (NDAs), biologics license applications (BLAs), or other submissions that are not generic drug submissions.
