I don’t have specific details, but I do know that the rules have been sent out for review, so once that process is complete it should hopefully not be too much longer. I’ll see if I can find someone more directly related to those activities that might be able to give you a more definitive update.
Thanks, Tim. Since I posted this question, I’ve learned that the SEND standards development team has been asked to review the rules and return comments by Aug 3, 2011.
Thanks, Tim. Since I posted this question, I’ve learned that the SEND standards development team has been asked to review the rules and return comments by Aug 3, 2011.
I’ve heard second-hand that an FDA employee indicated in the PDUFA IT meeting on July 22, 2011 that an open source validator would be available by end of fiscal year 2011.