Generic Application Quality Showing Signs Of Improvement

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.

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Usually a drop in FDA's generic drug metrics is a cause for alarm, but when it concerns refuse-to-receive actions, it may signal a breakthrough.

The agency's Office of Generic Drugs has reported significantly fewer refusals during the first two months of fiscal year 2017...

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