Joint briefing documents for the Oncologic Drugs Advisory Committee meetings are not intended to be a collaboration between the US Food and Drug Administration’s review team and the sponsor.
Point/Counterpoint: Combined Adcomm Briefing Document Not A Collaboration, US FDA Says
The development of a joint document is not iterative and there is no discussion between the agency and sponsor, according to new guidance seemingly aimed at differentiating the frequent use of joint backgrounders in oncology from the single document developed for the Alzheimer's drug Aduhelm.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
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Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.
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