CBER Reorganization Groups Hematology Products With Cell Therapies
Director Peter Marks makes his mark in shuffling of office divisions aimed at regulatory efficiency.
You may also be interested in...
Peter Marks takes over top spot in FDA's center for biologics after four-year training period as deputy director; his background appears well suited to what promises to be a transformative era in medicine.
FDA's working group on CBER/CDER consolidation will meet for the first time the week of Sept. 16
After US FDA's Oncologic Drugs Advisory Committee voted to delay approval of Karyopharm's multiple myeloma drug Xpovio, the company submitted some data from the Phase III BOSTON trial, which prompted the FDA to award an accelerated approval for a narrower indication.