US FDA Looks To Proactively Update Old Generic Drug Labels Under Pilot

Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.

FDA entrance sign 2016

The US FDA is interested in establishing a system where it can more easily drive generic labeling updates, rather than wait for sponsors to act independently.

Commissioner Scott Gottlieb said Jan. 26 during a panel at the World Economic Forum in Davos, Switzerland that the agency is looking to "initiate proactive updates on old generic drug...

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