US FDA Seeking New Orphan Products Office Director Amid Internal Moves
OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.
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Sandra Retzky worked at AstraZeneca and in Delaware's Medicaid fraud unit before joining the US FDA in 2016.
US FDA-related legislation among the bills moving during the lame duck session of Congress.
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.