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.
The US FDA is going outside the agency for help with Project Renewal, its pilot program to update the labeling of older cancer drugs.
The agency has retained a consultant to pull together research teams of scientific experts, which will review published literature and...
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
