Importation, Pricing Policies Raised Concerns For US FDA's Project Orbis
Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.
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Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.
US FDA oncology chief celebrates his 20th year at the agency with a frank and wide-ranging podcast interview in which he addresses the next (two) phases of the Oncology Center of Excellence, his ‘think it/do it’ mentality, and whether advisory committees still give good advice.
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.