SEND rules

RE: SEND RULES

Hi,

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.

Regards,
Tim

Thanks, Tim. Since I posted

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

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.

FDA PDUFA IT meeting July 22, 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.