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What Innovation Crisis? First-In-Class Drug Approvals Stable For Almost 25 Years, FDA Says

 
• By Cathy Dombrowski and Bridget Silverman

An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.

The conclusion of a recent FDA analysis of new molecular entity approvals that takes into account the true novelty of the drugs – that the level of innovation has been more consistent than raw NME counts suggest – holds up when put to the test of the past couple of years.

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