Indian pharma sees that the US FDA guidance calling for ANDA (abbreviated new drug application) labelling updates following revision of the RLD labeling can prevent false labeling issues. In the US, ...
If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates. The highly debated FDA generic-drug ...
More than three years after tossing a controversial proposal to allow manufacturers of generic drugs to update their labeling independent of the reference list drug (RLD) and promises that it would ...
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