New OND Director Could Be Hired Within Six Months, Woodcock Says
US FDA's Office of New Drugs has been without a permanent director for more than a year as it undergoes a significant restructuring.
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Amid concerns Office of New Drugs reorganization will result in sponsors receiving conflicting advice, new director offers several items already contemplated to prevent such problems.
US FDA May Wait Until Late 2019 Before A Cures Hiring Enhancement Is Available
Senior Biomedical Research Service expansion, used to attract elite scientists to federal service, may not be implemented until late 2019; FDA also may have a candidate for OND director.
CDER Safety Overhaul Planned As Review Process Modernization Continues
US FDA's Woodcock tells the Pink Sheet that goals include eliminating duplication through creation of one safety review process.