Problem
The US FDA has adopted a new technology for exchanging information between computer systems based on Clinical Document Architecture (CDA). A Sponsor is evaluating the requirements for a robust filing which meets appropriate eCTD requirements. Based upon the current requirements, which applies accurately to CDA?
a) CDA does not allow information to be exchanged in extensible markup language (XML).
b) CDA was developed based upon an ISO Standard.
c) The US FDA has adapted CDA for labeling in an HL7 standard called Structured Product Labeling (SPL).