Drugs

GDUFA Completeness Assessments Guidance

FDA has issued a guidance, Completeness Assessments for Type II API D MFs Under GDUFA, to make suggestions about information to be included in a drug master file (DMF) to facilitate a GDUFA completeness assessment. The document says it is intended for holders of Type 2 active pharmaceutical ingredient (API) DMFs that are or will be referenced in an ANDA, an amendment to an ANDA, a prior approval supplement to an ANDA, or an amendment to such a supplement.

Under GDUFA, DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application. Also, Type 2 API DMFs must undergo an agency completeness assessment.

The guidance does not apply to Type 2 API DMFs used to support NDAs, BLAs, other submissions that are not generic submissions, or any other types of DMFs.

The document includes an introduction and background information, completeness assessment, completeness assessment outcomes, and API information included in a generic drug submission.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome