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FDA, Industry Still Grappling With 'Consistent-With-Labeling' Guidance

 
• By Elizabeth Orr

In June, US FDA gave manufacturers permission to discuss their devices in ways that strayed outside the official labeling language as long as they met certain standards. FDAers and lawyers discussed the practical implications of that rule at a recent conference in Washington DC.

Printing at high speed on offset machine. Label, Rolled Up, Printing Out, Group of Objects, Merchandise

A guidance document finalized in June gave manufacturers more freedom to discuss devices in ways not specifically included in the labeling, but US FDA and industry are still feeling out the limits of the protection.

That was the message from two sessions at the Food & Drug Law Institute’s Advertising and Promotions Conference held this...

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