FDA Questions Innovation Gap, Says Me-Too Drugs Drive Approval Fluctuations
This article was originally published in The Pink Sheet Daily
Using first-in-class status as a sign of innovation, an FDA analysis finds approval numbers have been fairly stable during the past 25 years; the variability comes from follow-on products.
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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.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.