Updated US DMF Guidance Reflects GDUFA II, Electronic Submissions
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.
The pressure is on for API makers to submit higher quality Type II drug master files, or DMFs. FDA official says many US ANDA approvals are delayed by poor quality DMFs. A representative of the generic drug industry, however, contends that FDA is partially to blame for this problem by setting impractical expectations and an unrealistically high bar for DMFs.