Updated DMF Guidance Reflects GDUFA II
Draft FDA Guidance Also Requires Electronic Submission
US FDA’s first revision of its foundational Drug Master Files guidance in 30 years contains few surprises but incorporates statutory and regulatory actions. Among the changes: a new section requiring electronic submission of DMFs and a section reflecting GDUFA II completeness assessments in Type II DMFs.
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The 'technical detail' needed to be resolved in part to ensure there would be no shortages after the 2020 change from regulation as drugs to biologics for certain protein products, the agency said.
FDA has revised references in guidance to generic drug user fee requirements that changed under GDUFA II on Oct. 1. One guidance document no longer says for generics firms to pay user fees for prior approval supplement reviews. Another gives review goals for drug master file completeness assessments.
Under GDUFA, drug master files must pass a completeness assessment before they can be referenced in an ANDA. Sponsors should coordinate better with DMF holders to assure that FDA has adequate review time.