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BioWorld - Wednesday, June 4, 2025
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Home » FDA fixes ‘knowledge’ problem in draft version of revised intended use rule
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FDA fixes ‘knowledge’ problem in draft version of revised intended use rule

Sep. 22, 2020
By Mark McCarty
The U.S. FDA has posted another draft version of the intended use rule, this time with a fix for the so-called knowledge problem. This latest draft would eliminate mere knowledge of off-label use as a trigger for amendments to the product label, a provision the agency said in a Sept. 22 statement will “provide greater certainty and predictability for regulated parties.”
BioWorld BioWorld MedTech Regulatory U.S. FDA

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