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Home » FDA to Use QbR in DMF Filings to Speed Reviews, Boost Quality
FDA to Use QbR in DMF Filings to Speed Reviews, Boost Quality
June 5, 2012
To promote more thorough ANDA filings and faster reviews, the FDA’s Office of Generic Drugs (OGD) plans to extend its quality-based review (QbR) process to Type II drug master file (DMF) submissions, FDA officials say.