Generic Drug Review: US FDA Approves More ANDAs Than It Receives For First Time Since Early 2016
Among the 61 approvals in February appear to be ANDAs from the official GDUFA backlog, which have been pending for more than four years.
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US Generic Reviews: Would Pre-Submission Meetings Be Better Than Six-Month Priority Review?
Lawmakers inquire about expanding pre-submission meetings to include non-complex priority ANDAs, suggesting it could be another way to help deal with drug pricing issues.
Generic Drug Review At US FDA: Has Submission Rush Ended Or Just Paused?
Excitement to get a 10-month ANDA review may have waned in January as submissions plummet, but can approvals keep up?
ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System
As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.