FDASIA Study Mandates Focus On Performance, But Could Slow Reviews

Under FDASIA, FDA will be required to complete many new performance studies and reports. This article quotes Catalyst’s Nancy Bradish Myers on the potential effect of these new requirements on staff capacity for new drug review activities.

FDASIA Study Mandates Focus On Performance, But Could Slow Reviews

The Pink Sheet

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2018-05-24T23:10:50+00:00