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    A Lifecycle Approach to ANDA Filings: Lessons Learned

    This article discusses the benefits of implementing a lifecycle approach to ANDA filings to avoid refuse-to-receive notices and deficiencies, ensuring readiness for preapproval inspections. With more than 2,000 Abbreviated New Drug Applications (ANDAs) awaiting review or inspections in 2012, the US Food and Drug Administration (FDA) received additional resources to tackle this backlog with the enactment of the Generic Drug User Fee Amendment (GDUFA ), designed to spee...