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Drug manufacturers choosing to submit applications to the U.S. 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, a U.S. Food and Drug Administration (FDA) official said.
In an effort to ease manufacturers into electronic common technical document (eCTD) formatted submissions, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is accepting electronic submissions that are compliant with the folder structure and naming conventions of the eCTD standard but which lack an extensible markup language (XML) backbone.
The FDA is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form (CRF) data in extensible markup language (XML) based on the operational data model (ODM) developed by the Clinical Data Interchange Standards Consortium.
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.
The International Electronics Manufacturing Initiative (iNEMI) has started a "Medical Components Reliability Specifications Project" to develop testing and guidelines for electronic components and circuit boards used in medical devices.
The FDA is inviting clinical trial sponsors to participate in a pilot project to test the electronic submission of case report form (CRF) data in extensible markup language (XML) based on the operational data model (ODM) developed by the Clinical Data Interchange Standards Consortium.