The skinny lineup of applications with US FDA user fee goal dates in July is heavy on incremental benefits from formulation technology, the Pink Sheet US FDA Performance Tracker’s User Fee Goal Dates tracker shows.
US FDA’s Dry July? Few Goal Dates Portend Quiet Month For Approvals
Sun’s deuruxolitinib and Novo Nordisk’s insulin icodec stand out as new molecular entities among the small cluster of US FDA user fee goal dates in July.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.