Home » Quality Questionnaire Planned for DMFs to Boost ANDA Quality, Speed Reviews
Quality Questionnaire Planned for DMFs to Boost ANDA Quality, Speed Reviews
May 23, 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.
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