Questionnaire Planned for DMFs to Boost ANDA Quality, Speed Reviews

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. The process is already used to evaluate chemistry, manufacturing and controls (CMCs) in ANDAs.
Washington Drug Letter