MASSDEVICE ON CALL — The FDA this month issued a formal warning to the Institutional Review Board of Mercy Hospital & Medical Center, citing the committee for violations of policies regarding human clinical testing.
The feds noted record-keeping and protocol violations regarding the board’s clinical trial , the keeping of meeting minutes and other breaches, and said that the board’s initial responses to some of the concerns were "inadequate."
"The response is inadequate because it does not describe any process that the IRB will use to train and educate IRB members, staff, and clinical investigators with respect to its revised written procedures and checklists, nor does it provide projected implementation and completion dates," according to the FDA warning letter."Without this information, FDA cannot conduct an informed evaluation of the proposed corrective and preventive actions’ potential ability to prevent the recurrence of these or similar violations in the future."
Another study urges mammograms for women in their 40s
A group of Ohio doctors jump into the debate over mammograms for younger women, urging routine screening for women in their 40s in order to catch potential cancers earlier and potentially avoid invasive surgeries or the need for chemotherapy.
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Web giants sued over prosthetic material sales
Both eBay and PayPal were the targets of lawsuits filed this month in California, accusing the internet giants of unfairly blocking vendors from selling materials for use in building prosthetics.
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A smartphone app for childhood cancer survivors
Akron Children’s Hospital took a $100,000 grant from Hyundai Hope and turned it into CancerLateFX, a mobile app to help survivors of childhood cancer cope with late side effects of the disease.
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