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- FDA releases weekly update on user fee letters and new HHS regulatory agendaThe FDA's latest weekly briefing highlighted the release of user fee commitment letters, which outline the agency's financial planning for upcoming fiscal periods. It also introduced a new regulat…
- FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in ChinaThe U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…