Ethics/Regulatory

FDA warns Sironis for unapproved trial

Monday, September 28, 2015

The FDA has sent a warning letter to Sironis, a medical devices and software developer, for running an unapproved clinical trial of its LIR closed-loop fluid administration system. The FDA said the Newport Beach, Calif.-based company never sought the proper approvals.

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NIH seeks ways to combine genomic information and EHRs

Wednesday, September 9, 2015

A dozen awards from the NIH will support research that incorporates DNA sequence information into electronic medical records. The goal of research conducted by the Electronic Medical Records and Genomics (eMERGE) network is to better understand the genomic basis of disease and to tailor medical care to individual patients based on their genomic differences.

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Medical writers rail against Sunshine Act

Tuesday, September 8, 2015

Citing insufficient professional guidance on how to interpret certain elements of the Physician Payments Sunshine Act, a group of seven medical writers and editors has concluded that difficulty could have a “chilling effect” on physicians’ ability to participate in clinical trials and publish results.

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