FDA Issues Final Guidance on Type II API DMFs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-16-2016 15:19


The US Food and Drug Administration (FDA) has issued final guidance, Completeness Assessments for Type II API DMFs Under GDUFA.

This 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), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions). The guidance explains that, as of October 1, 2012, under the Generic Drug User Fee Amendments of 2012, commonly referred to as GDUFA, several requirements apply: 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 completeness assessment (CA).

The guidance makes recommendations about the information that should be included in the DMF to facilitate a GDUFA CA. The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), biologics license applications (BLAs), other submissions that are not generic drug submissions, or any other types of DMFs.

Source: FDA 



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