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What is a “Changes Being Effected” (CBE) supplement?

April 26, 2017CBE supplement

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What is a “Changes Being Effected” (CBE) supplement?

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A CBE is a means available under FDA regulations to allow a company and the FDA to promptly address an important safety issue. This process allows a company and the FDA to expedite the review, approval process, and distribution for revised prescribing information when safety issues arise.