On Nov. 21, 2017, Portola Pharmaceuticals (PTLA) announced that the U.S. Food and Drug Administration (FDA) has informed it that it will respond to the Prior Approval Supplement (PAS) request to change the current manufacturing release specification within the standard 60-day extension period.
No additional information was requested at this time. The new action date is January 30, 2018.
Bill Lis, chief executive officer of Portola said, “As we communicated earlier this month, we’ve made good progress with the FDA and have established an agreement in principle on the change to our product . . .
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Today’s Highlights November 24, 2017