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In early June, FDA published the proposed updated guidance, which addresses common questions about health care economic information that companies are able to share with payors, formulary committees, and similar entities conducting healthcare economic analysis of their approved and cleared products and products before they've been approved or cleared by the agency
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One practical consideration worth flagging: the pill must be taken on an empty stomach in the morning (after fasting for at least eight hours), with up to 120ml of plain water, followed by a 30-minute wait before eating, drinking anything else, or taking other oral medications
