FDA: seeks input on Study Data Exchange Standards

FDA seeks "input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. " 

In the annoncement for a meeting 5 November FDA ask for responses, before 5 October, on questions such as "- What are the advantages and disadvantages of HL7 v3 and CDISC ODM?"

And, interestingly, they also ask: "- Are there other open data exchange standards that should be evaluated?"

Is this an opportunity for a semantic web based proposal? 

Kind Regards

Kerstin Forsberg

AstraZeneca






https://www.federalregister.gov/articles/2012/08/14/2012-19748/regulatory-new-drug-review-solutions-for-study-data-exchange-standards-notice-of-meeting-request-for