Generic Sponsors Need To Increase Communications About Drug Master Files, US FDA Says
Industry complaining about issues in DMF completeness assessments, but few sponsors schedule teleconferences after complete response letters, FDA says.
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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.