Compliance
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Unresolved Issues With 'Right to Try'
New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access recently issued a statement that cited unresolved issues on the federal Right to Try law.
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Right to Try Law in Regulatory Limbo
The new Right to Try law has been dogged by implementation questions and remains in regulatory limbo.
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Vaccinated Healthcare Worker Acquires Measles Amid Outbreak
A healthcare worker with a history of measles vaccination still acquired the disease when treating unsuspected cases in the early stages of a large measles outbreak in the Minneapolis area last year.
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FDA Proposes Including Children in Adult Cancer Trials
IRB members have until Aug. 3, 2018, to submit comments on FDA draft guidance that would open adult oncology clinical trials to children ages 12 to 17 years.
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IRBs Can Learn to Make the Most of Central IRB Partnerships
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago — long before the new Common Rule encouraged IRBs to designate an IRB of record for multisite studies.
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IRBs and IBCs: Critical Partners in Gene Research
In addition to IRB oversight, the National Institutes of Health requires that research using “recombinant or synthetic nucleic acid molecules” for gene transfer into human research subjects be approved by institutional biosafety committees.
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FDA Explains IRB Written Procedures Policy
New federal guidance on IRB written procedures leave “meaningful content” open to interpretation.
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$16 Million Verdict for Errors Leading to Amputations of Thumb and Toes
Failure to diagnose and treat a patient's vasculitis led to amputations.
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Negligent Post-fall Treatment of Snowboard Coach Leads to $6.3 Million Verdict
Despite the patient's symptoms, the patient's compartment syndrome was not diagnosed or treated for several days.
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$114 Million Penalty in Medicare Fraud Case by Whistleblowers
A federal judge in South Carolina imposed civil damages and penalties totaling more than $114 million on the former CEO of a medical testing lab and two owners of the lab’s marketing partner for violations of the False Claims Act.