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
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Web giants sued over prosthetic material sales
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A smartphone app for childhood cancer survivors
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