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.
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Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.
US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.
As coronavirus spreads into China’s manufacturing region, quarantines and travel restrictions challenge international flow of pharmaceuticals, ingredients and personnel.