Generic Labeling Rule Defies Predictions, Remains In FDA's Long-Term Pipeline

 
• By Michael Cipriano

Policy that would allow generic sponsors to change product labels has been delayed yet again, not spiked completely, even with Commissioner Gottlieb's known opposition to the rule.

Machinery cogwheels, industry concept

When Scott Gottlieb was tapped by President Trump to be commissioner of the US FDA, it was almost a forgone conclusion that the agency would scrap a proposed rule that would allow abbreviated new drug application (ANDA) sponsors to change their product labels without getting prior approval.

But at least for now, it appears FDA is simply pushing the proposed rule to the backburner.

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