First-In-Class Drugs Are True Barometer Of Industry Innovation, FDA Says
The agency suggests that categorizing approved drugs by level of novelty and tracking approvals by category is a better metric than NME count and should be the basis for assessment of the programs created by FDASIA to speed development of innovative products.
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With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.
The new molecular entity and novel biologic class of 2011 isn’t just the largest since 2004 – CDER also posted near-perfect on-time review performance while maintaining healthy rates of first-cycle approvals and a low 15 month average time to approval, thanks to a high level of innovation in the novel product candidates.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.