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Latest From Accuray Incorporated

FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.

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Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind

Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.

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Mifepristone Ruling Casts ‘Shadow Of Uncertainty’ Over All FDA Approvals, Drug Industry Tells Supreme Court

As Supreme Court term begins, PhRMA and host of pharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court also will consider lawsuit challenging deference to federal rulemaking and may consider another that would increase corporate liability under Anti-Terrorism Act.

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Mifepristone Ruling Casts ‘Shadow Of Uncertainty’ Over Every FDA Approval, Biopharma Industry Tells Supreme Court

As the new Supreme Court term begins, PhRMA and a host of biopharma CEOs and investors implore justices to take up mifepristone case to prevent chaos for drug development. High court will also consider a lawsuit that would reduce deference to federal rulemaking and it may consider another that would increase corporate liability under the Anti-Terrorism Act.

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Company Information

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  • Medical Devices
  • Medical Devices
    • Diagnostic Imaging Equipment & Supplies
    • Diagnostic Imaging Equipment & Supplies
      • Digital Imaging
  • Other Names / Subsidiaries
    • TomoTherapy, Inc.
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