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Latest From Kate Rawson
Anand Shah returns to FDA as deputy commissioner; like Abernethy, he is an oncologist with a background in big data.
Resubmission comes more than four years after Purdue pulled an sNDA seeking to demonstrate ‘real-world’ abuse prevention.
FDA has been criticized in recent months for approving drugs too quickly, based on insufficient evidence. The agency’s oncology chief Richard Pazdur fights back.
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.
ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week.
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.