FDA expectations for the next fiscal year of ANDA approvals and submissions appear to be underestimated.
At the same time, the Office of Generic Drugs is expecting median approval times to drop by several months, indicating...
FDA's Generic Drug Workload, Productivity Beating Budget Estimates
ANDA submissions and approvals for FY 2017 likely to be higher than agency estimates, but FDA also predicts improved median approval time.
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