Cancer Drugs: US FDA Looks Outside For Help On Generic Labeling Updates
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.
You may also be interested in...
Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.
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.
Agency seeks legislative authority to update outdated generic drug labels when the reference product has been withdrawn.