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FDA rethinking "black box" label for opiates

A newly released letter sheds light on the possible change.

In June, we told you about how members of Congress are calling on the FDA to label immediate-release opiates with the same "black box" warning as those found on extended-release versions of the drugs.

Well, according to a just-released Aug. 12-dated letter, the FDA may reconsider their policy.

According to FDA News, the FDA told lawmakers in that letter, "a citizen petition to require the same warnings for immediate-release opioids is under “active consideration.”"

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Fresh from the show floor: pharma packaging innovations for 2026