Generic Labeling: FDA Ponders Global Process Uniformity
This article was originally published in The Pink Sheet Daily
Executive Summary
Generic firms argue their data is not sufficient to recommend safety labeling changes, but FDA’s Dal Pan asks if they recommend changes in other countries, shouldn’t they be able to do the same in the US?
You may also be interested in...
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Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.
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Concept mentioned during Gottlieb’s 'star' turn at Davos may sound similar to now-withdrawn generic labeling rule, but actually appears based on a proposal from the Friends of Cancer Research to get current clinical guidelines reflected on labels.
Gottlieb Q&A: Sen. Murray Wants To Know About Generic Labeling Rule
US FDA Commissioner nominee offers master class in how to respond to congressional inquiries – and throws in some policy insight for good measure.