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FDA Week - 09/21/2018

  • Senate Passes Opioid Legislation, But Changes In Store Before Conference

    Following months of legislative debate involving myriad committees, the Senate on Monday (Sept. 17) passed an extensive package of opioid legislation by a vote of 99-1, but a new version privately hammered out by senators from both parties will be taken to conference with the House, a Senate aide told Inside Health Policy. The bill passed by the Senate on Monday is an older version that will be updated prior to conference to include the changes, according to the aide, who did not describe the revisions.

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  • FDA Adds Immediate-Release Opioids To REMS, Revises Education Blueprint

    FDA for the first time has applied its opioid safety protocols to immediate-release (IR) opioids intended for use in an outpatient setting and is requiring that training be made available to nurses and pharmacists -- not just prescribers -- who are involved managing patients with pain, the agency announced Tuesday (Sept. 18).

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  • JUUL Says It Will Address Youth E-Cig Use; Groups Doubt Industry Will Act

    E-cigarette manufacturer JUUL Labs says it will work with FDA to devise a plan for how the company can address the widespread youth use of e-cigarettes, coming in response to FDA Commissioner Scott Gottlieb's announcement that the agency will take enforcement action if JUUL and four other major e-cigarette manufacturers do not respond to the agency's request that they develop plans to reduce youth access and use within 60 days.

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  • CA Insurance Chief Sues AbbVie For Alleged Kickbacks To Promote Humira

    California is suing AbbVie for allegedly offering providers kickbacks to prescribe Humira, an expensive arthritis drug that has also come under fire on Capitol Hill due to steep price increases.

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  • White House Places HHS At Helm Of National Biodefense Strategy

    HHS Secretary Alex Azar will chair a new cabinet-level interagency biodefense steering committee launched by the White House as part of a new National Biodefense Strategy unveiled Tuesday (Sept. 18).

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  • FDA Finalizes DSCSA Compliance Policy, Grandfathered Exemption Guides

    FDA issued three guidances -- two final and a new draft guide -- intended to help drug manufacturers and repackagers prepare to comply with the upcoming deadline for including product identifiers on product packages or cases, and to help them understand when product packages are exempted from the requirements, known as a grandfathering exemption.

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