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Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA 

FDA has published guidance for industry on ” Initial completeness assessment for Type II API DMF’s under GDUFA. 

Under GDUFA, beginning October 1, 2012, the holder of a Type II API DMF must pay a onetime DMF fee when it first authorizes in a letter of authorization (LOA) the reference of its DMF in an ANDA, an ANDA amendment, or an ANDA PAS.  Holders of DMFs that were evaluated before October 1, 2012 will also be required to pay a fee for the DMF when their DMF is first referenced in a new ANDA, an ANDA amendment, or an ANDA PAS on or after October 1, 2012.   

In addition, GDUFA requires Type II API DMFs to undergo an initial CA to ensure that the DMF is complete.  Although the requirement for an initial CA for Type II API DMFs is new, the elements of the initial CA have been used previously by FDA to evaluate DMFs.  DMFs that have paid the fee and been found to be complete in accordance with the criteria for an initial CA set out in the attached checklist will be identified on FDA’s public Web site as available for reference in support of a generic drug submission.  When submitting a DMF, the DMF holder should also submit Form FDA 3794, the Generic Drug User Fee Cover Sheet, which requests the minimum information necessary to determine if a DMF holder has satisfied all relevant user fee obligations. 

This draft guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug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 the Generic Drug User Fee Amendments of 2012, commonly referred to as 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. 

FDA will perform an initial CA once a DMF holder files a Type II API DMF with the generic drug user fee cover sheet (Form FDA 3794) and the fee payment has been verified.  

The initial CA does not replace the full scientific review, which is performed to determine the adequacy or inadequacy of the information contained in the DMF to support an ANDA review decision.

In brief, FDA will undertake an initial CA to determine the following: 

Is the DMF active?

Has the fee been paid?

Has the DMF been previously reviewed?

Does the DMF pertain to a single drug substance?

Does the DMF contain certain administrative information?

Does the DMF contain all the information necessary to enable a scientific review?

Is the DMF written in the English language? 

FDA will conduct the initial CA by completing a series of questions listed in the GDUFA Initial Completeness Assessment Checklist for Type II API DMFs, This guidance provides additional detail on the kinds of information FDA will confirm when performing an initial CA on a DMF.