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Regulatory Whitepapers

These links will take you to the West's Regulatory whitepapers on Westpharma.com.
The US Food and Drug Administration (FDA) recently issued a draft guidance: Comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, January 2017...

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West Knowledge Center
Back to results

Regulatory Whitepapers

These links will take you to the West's Regulatory whitepapers on Westpharma.com.
The US Food and Drug Administration (FDA) recently issued a draft guidance: Comparative analyses and related comparative use human factor studies for a drug-device combination product submitted in an ANDA, January 2017...

Please Signup/Login to see the full article.