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Jun
01

PDUFA passes

So I blogged about this before–  based on press reports the PDUFA bill has passed ! This could have big implications for getting drugs for rare diseases. Personally this legislation is long overdue and it will be interesting to see how the FDA responds and also the impact it might have on drugs approved over the next few years. Something had to be done because of the dire approval rate of new drugs – however this legislation may not impact the pharma productivity side, unless they undergo some radical rethink or disruption of how drug discovery & development occurs.

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