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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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.
Biosimilar availability may not be in the its purview, but the FDA still is thinking about ways to help industry deal with the issue and support sector growth.