US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development
Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
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The Pink Sheet's table of the 55 novel products approved in either the US or EU during H1 2021 includes details on approval dates, use of special review pathways and review status such as orphan product or priority review.
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