Pharma Looks To America First: US FDA Holds Overwhelming Lead Over EMA In Novel Approvals

A Pink Sheet analysis finds US approval preceded European Union clearance for 80% of products approved in both areas, but when EU approval came first, it beat the FDA by a median of 13 months. US-first approvals came close to six months before the EU.

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NOVEL DRUGS FOLLOW DIFFERENT REGULATORY ROADS IN THE US AND EUROPE, BUT ONE IS FASTER. • Source: Shutterstock

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