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Drug manufacturers choosing to submit applications to the Center for Drug Evaluation and Research (CDER) electronically -- as opposed to on paper -- will have to use a particular electronic format called the electronic common technical document (eCTD) starting Jan. 1, 2008, an FDA official said.
Implanting a microchip or similar monitoring device in a patient without obtaining the patient’s written consent would be a third-degree felony offense under a bill unanimously approved by a Florida Senate committee March 21.
Researchers are urging more comprehensive imaging for patients with stroke symptoms after a recent study showed magnetic resonance imaging (MRI) and echocardiography together improve detection of cause and selection of treatment for cardioembolic strokes, the “meanest” type of stroke, according to the Society of Interventional Radiology (SIR).
A new class of compounds could have applications as an antimicrobial coating on a range of implantable medical devices, Ceragenix Pharmaceuticals said last week.
The FDA is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form data in extensible markup language based on the operational data model developed by the Clinical Data Interchange Standards Consortium.
Allscripts, a clinical software firm, has entered into agreements with ambulatory care providers to connect more than 60 medical
devices to electronic health records (EHRs).
As telemedicine becomes more prevalent, healthcare facilities need to determine which regulations and reimbursement policies apply and bear in mind potential legal issues, a recent ECRI report says.
As telemedicine becomes more prevalent, healthcare facilities need to determine which regulations and reimbursement policies apply and bear in mind potential legal issues, a recent ECRI report says.