BIO Notebook Day 3: ARM Launches Foundation To Educate Public About Gene And Cell Therapies
Alliance for Regenerative Medicine initiative seeks to explain gene and cell therapy to the general public. Also, EY's Giovannetti says strategic decisions, not tax reform, should drive deal-making; FDA's Woodcock touts benefits of new drug review office overhaul; and Siga Technologies eyes priority review voucher upon approval of Tpoxx for smallpox.
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Keeping Track: Tpoxx Wins Green Light For Smallpox, Submissions Galore, And A Broader Approval For Xtandi
Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.
In another sign of the increasing influence of generics within FDA, CDER Director Woodcock moves the formal dispute resolution program out of the Office of New Drugs.