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FDA Updates Draft Guidance on Promotional Labeling and Advertising Considerations for Biological Reference Products and Biosimilars | King & Spalding

On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and.

King spaldingPromotional labelingAdvertising considerationsPrescription biological reference productsBiosimilar productsInterchangeable biosimilar productsRevised draft guidanceClient alertBiosimilar user fee amendmentsRevised draftDraft guidanceProcedures fiscal yearsPrescription biological reference

FDA Issues Revised Draft Guidance on Off-Label Communications to Health Care Providers – Expanded Scope, Yet Limitations Remain | Dechert LLP

The FDA issued Revised Draft Guidance addressing communications by drug and device manufacturers about “off-label” uses of approved products. The Revised Draft Guidance.

Categories of communicationsCommunications should not use persuasive marketing techniquesDevice manufacturer communications with payorsDrug administrationCommunications should be clinically relevantRevised draft guidanceMedical publicationsUnapproved new usesFrom firmsUnapproved usesCleared medical productsRecommended practicesFederal foodCosmetic actDraft guidanceDifferences between

FDA Guidance on Unapproved Use of Approved Medical Devices

FDA Guidance on Unapproved Use of Approved Medical Devices
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Revised draft guidanceCommunicating scientific informationUnapproved usesCleared medical

Health Care Week in Review: Congress Raises Debt Ceiling, CMS Issues Final Rule | Alston & Bird

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and.

United statesNew mexicoCarrie lukasChristopherj cj frisinaJanet yellenGarrett lee smithCheryl mormanKathryn larinJoe bidenElizabeth groginskyBrian leeLauren hoganOther health policy newsUs senateAdvisory committee on immunization practicesClinical laboratory improvement amendments

Washington Healthcare Update - October 2021 #2 | McGuireWoods Consulting

This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed.

United statesNew mexicoMelanie anne egorinMike crapoXavier becerraFrancis collinsRevenue serviceSenate republicansUs district courtCenters for medicareCommerce committee health subcommitteeDepartment of healthDepartments of healthHouse committee leadership write to agencies regardingHealth system compounding under sectionTaro pharmaceuticals united states