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.

US Food & Drug Administration’s program to revise out-of-date prescribing information on widely used generic cancer therapies is offering the agency some learning opportunities in much the same way that officials hope that physicians and patients can benefit from the labeling updates.

Launched in 2018 by the Oncology Center of Excellence as “Project Renewal,” the label update effort is clearly one of the most resource intensive efforts the new integrated cancer products...

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