The US Food and Drug Administration (FDA) has issued final guidance on the electronic submission of documents related to the Risk Evaluation and Mitigation Strategies (REMS) using the Structured ...
The extensible markup language (XML) format facilitates compliance with FDA's new requirements for prescription drug labeling submissions, improves patient safety, and enhances manufacturing sponsor ...
According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) ...