US FDA's Patient Affairs Office Is An Office … In Spirit
Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.
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Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors
Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.
Orphan, Combo, Pediatric Products Would See More Influence In Proposed US FDA Reorg
Reorganization also may force change to commissioner succession plan.
US FDA/NORD Partnership Will Further Increase Patient Involvement In Drug Development
Agency's agreement with rare disease advocacy group will facilitate patient meetings with review divisions, as well as enhance communication of safety information.