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We believe including the reference product's data in the blended calculation for a biosimilar's payment limit in the limited circumstance described could be appropriate in determining an operationally reasonable payment limit because the FDA approval for the biosimilar relies in part on FDA's previous determination of safety, purity, and potency for the reference product, and the biosimilar and reference product are necessarily approved for at least one shared condition of use, as required under the 351(k) approval pathway

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A menthol smoker might compare Rolled Gold Menthol with Rolled Gold Light to decide whether the cool finish or the lighter body matters more

Vitamin-infused nicotine-free inhalers offer a fundamentally different approach: maintain the ritual, swap addictive chemicals for positive ingredients, spend less, and avoid the oral health damage that comes with holding nicotine against your gums 812 times a day

She declined to say how much of an increase the group will propose

We even have hints about the brain structures that house the decision-making circuitry