publication date: Dec. 16, 2016
Issue 46 - Dec. 16, 2016
  • FDA Finds Lapses in Reporting of Patient Harm, Deaths Resulting from Medical Devices in Hospitals Nationwide

    After a broad survey of reporting standards at hospitals across the U.S., an FDA investigation recently concluded that the vast majority of the 17 institutions inspected did not file timely reports of injuries and deaths caused by medical devices.

    The inspections earlier this year were triggered by public scrutiny of power morcellation, a surgical procedure known to spread undetected uterine cancer via the device’s spinning blades, as well as by reports of infections associated with contaminated duodenoscopes, flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine.

  • Conversation with The Cancer Letter

    FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary

    In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn’t have proper reporting and documentation procedures in place.

  • Hackensack Cancer Center, MSKCC Form Business, Clinical Partnership in New Jersey

    Memorial Sloan Kettering Cancer Center and Hackensack Meridian Health announced a 10-year partnership deal that, in its initial stages, will involve developing joint standards of care that will be applied across their operations.

  • Obama Signs Cures Act, Funding Biden’s Moonshot and Boosting NIH, NCI, FDA Budgets Over 10 Years

    President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 million over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative.

  • Editorial

    The Year of the Moonshot

    The moonshot, The Cancer Letter’s biggest area of coverage of 2016, continues into 2017.

    With the passage of the 21st Century Cures Act, the cancer moonshot initiative has been authorized at $1.8 billion over seven years. The Cures Act also authorizes $500 million over the next decade for FDA to streamline drug and device approval processes (The Cancer Letter, Dec. 10).

  • In Brief

    • Bertagnolli elected ASCO president
    • CMS abandons Medicare Part B payment experiment
    • Maki joins leadership of Northwell Health and Cold Spring Harbor
    • Neufeld named clinical director, physician-in-chief & EVP at St. Jude
    • Anderson appointed CEO of Genentech
    • Brown gives $30 million to IU immunotherapy center
    • Mulva family donates $75 million to UT Austin, MD Anderson
    • Collins receives FASEB Public Service Award
    • Proton Partners to build new cancer center at Thames Valley Science Park, UK
    • ACCC launches online resource for metastatic breast cancer
  • Drugs & Targets

    • Keytruda becomes first anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated NSCLC
    • Nintedanib receives orphan drug designation for mesothelioma
    • ABTL0812 receives orphan drug designation for Pancreatic Cancer

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