US FDA's Stein To Sponsors: New Leadership From OND Reorganization Won't Change Your Development Plans
Office of New Drugs Director Peter Stein told sponsors during a panel discussion that they will be able to continue agreed upon development programs despite leadership changes arising from the OND reorganization; industry speakers excited, but also have some reservations, about the new OND.
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CBER’s New Home For Gene Therapies: OTAT Changes To OTP But Leadership Questions Remain
US FDA has not named permanent heads of several offices within the new Office of Therapeutic Products, the only super office in the Center for Biologics Evaluation and Research.
US FDA Office Of New Drugs Reorg: Phase 3 Pushed To January
The FDA has confirmed the picks to head most of the new offices in the restructured drug review organization, with one notable exception. The choice for the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine is still pending, while one candidate – Hylton Joffe – will be serving as acting OND deputy director.
Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
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.