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?
You may also be interested in...
As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.
US FDA’s monthly refuse-to-receive numbers for ANDAs are down early in FY 2017, suggesting that sponsor have an increased understanding of the agency’s standards.
US FDA receives more than 100 ANDAs during the first month of GDUFA year five, suggesting sponsors want the new 10-month review goal and cheaper user fee.