Articles Tagged with ''Technology''

CDER to Require eCTD Format for Electronic Submissions

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.

Read More

MHRA Offers Firms Flexibility in Electronic Submissions -- for Now

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.

Read More

FDA Pilot Project Solicits Electronic Case Report Forms

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.

Read More

CDER to Require eCTD Format For Electronic Submissions

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.

Read More

FDA Pilot Project Solicits Electronic Case Report Forms

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.

Read More