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What to Consider When Prescribing Off-Label

    https://psychnews.psychiatryonline.org/doi/10.1176/appi.pn.2019.7b21
    The FDA defines off-label drug use as “use of drugs for the indication, dosage form, regimen, patient, or other use constraint not mentioned in the approved labeling.” Further, the FDA states that when physicians prescribe a medication off-label, …

Off-Label Use of Medical Products - ECRI

    https://www.ecri.org/components/HRC/Pages/LawReg17.aspx
    Classifications Share Executive Summary "Off-label" use of medical products (i.e., drugs, devices, and biologics) is the practice of prescribing drugs and biologics, and …

The Law and Practice of Off-Label Prescribing and …

    https://jaapl.org/content/early/2020/11/24/JAAPL.200049-20
    With any off-label use, physicians look to evidence-based studies or guidelines that validate the use of a medication for an off-label use as beneficial for …

How to Avoid Malpractice Risks When Prescribing Off-Label

    https://journals.lww.com/neurotodayonline/Fulltext/2008/10160/How_to_Avoid_Malpractice_Risks_When_Prescribing.12.aspx
    OFF-LABEL USE IS NOT ILLEGAL. Jacqueline M. Melonas, JD, RN, a health care attorney and the vice president of risk management at Professional Risk …

Prescribing “Off-Label”: What Should a Physician Disclose?

    https://journalofethics.ama-assn.org/article/prescribing-label-what-should-physician-disclose/2016-06

    Understanding Unapproved Use of Approved Drugs "Off …

      https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
      Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, …

    [Research Status on Off-label Use in Appraisal for …

      https://pubmed.ncbi.nlm.nih.gov/29923385/
      Off-label use is widely happened in medical practice. But for now, there is no clear legalistic demarcation for the behaviour of off-label use. Even in medical and legal …

    Medical Malpractice – Off Label Use of Medical Devices and Drugs

      https://www.marylandmedicalmalpracticelawyerblog.com/medical_malpractice_off_label/
      While off label use of a medical device may be legal, a prescription drug or medical device should not be used “off label” without a patient’s consent. In …

    Off-label use of medicine and medical malpractice: court finds ...

      https://www.lexology.com/Commentary/healthcare-life-sciences/greece/zemberis-markezinis-lambrou-associates/off-label-use-of-medicine-and-medical-malpractice-court-finds-ophthalmologist-liable-for-vision-loss
      'Off-label' use is defined as the unapproved use of a medicinal product which has regulatory approval for other medical uses (and should not be confused with …

    Medical Malpractice Litigation Due to Off-Label Use of …

      https://www.researchgate.net/publication/368188098_Medical_Malpractice_Litigation_Due_to_Off-Label_Use_of_Bone_Morphogenetic_Protein
      Case inclusion criteria was defined as a plaintiff's basis of litigation resting on a claim of medical malpractice due to off-label use of BMP. Additional collected data …



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