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Labeling Updates For Old Drugs Could Be Faster Under Streamlining Proposal

 
• By Sue Sutter

Stakeholder group's proposed pilot program to correct outdated drug labeling calls for US FDA to identify older products needing updates and contract out for evidence reviews, but agency and generic drug industry raise concerns about complexity, resources and product liability.

Arrow flying to target with radial motion blur
Can Friends of Cancer Research's proposal to update labeling hit the target and not harm anything else?

A streamlined pathway for adding important data to labeling of older drug products could encourage submission of more labeling supplements to better reflect products' current clinical use, but the idea seems to lack strong support from the US FDA and the generic drug industry due to a host of factors including complexity, resources and product liability concerns.

The proposal, aimed at bringing labeling for older drugs into line with current real-world practice, was introduced at the Friends...

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