Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates
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.
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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.
Under the Oncology Center of Excellence’s Project Renewal, agency has contracted with consulting firm Deloitte to establish subject matter expert research teams that will review published literature on off-patent drugs and suggest labeling updates.
Agency has targeted 40 older generic chemotherapeutics for revised labeling; FDA will develop the new labeling, which will include currently accepted uses, but needs the cooperation of reference product holders who would actually have to submit the supplement.