House Bills Would Close Orphan Exclusivity ‘Loophole’ And Thaw ‘Frozen’ Generic Labeling
US FDA-related legislation among the bills moving during the lame duck session of Congress.
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Capecitabine’s existing indications were revised and new indications added, reflecting uses that long have been considered standard of care; however, the cancer drug's label had been frozen in time since the approval of generics.
Sandra Retzky worked at AstraZeneca and in Delaware's Medicaid fraud unit before joining the US FDA in 2016.
OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.