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Will Antimicrobial Breakpoint Changes Signal Shift To Online Labeling Updates?

 
• By Derrick Gingery

FDA must place antimicrobial breakpoints that usually appear in labeling on a website so they can be more regularly updated. CDER Director Woodcock said that could become a precedent for other electronic labeling changes.

FDA entrance sign 2016

A mandate that FDA take antimicrobial breakpoint data out of drug labels and place it online could serve as the precursor for other labeling changes, including a shift of information away from paper to an electronic format.

The agency is in the process of implementing a provision in the 2016 21st Century Cures Act requiring the breakpoint...

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