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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China Unlikely To Be Included In US FDA's Project Orbis In The Near Term
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.
Richard Pazdur: 20th Anniversary Edition
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.
Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.