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Latest From Review Pathway
The latest developments in one of the US FDA's favorite pathways.
Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.
Progress is being made with redistributing UK rapporteurships for non-centrally approved medicines, but companies need to keep up the momentum if all procedures are to be reallocated to other EU countries by the Brexit date of March 29, 2019.
Providing access to unlicensed medicines can offer companies big strategic advantages.
The first half of the year was pretty bleak for companies seeking fast-track review of their products in the EU. There has been much better news in the second half. The Pink Sheet tracks the winners and losers.
New treatments for spinal muscular atrophy, glioblastoma, Gaucher's disease and others could be soon be hitting the China market following the awarding of priority reviews to a large list of novel therapies.
Ipsen’s tyrosine kinase inhibitor, Cabometyx, is the first product to be registered under a new Australian procedure that aims to get prescription drugs to market faster by using medicine assessments already conducted by comparable overseas regulators.
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