Before revision: An additional Draft Implementation Guide was released in February 2015 Draft specifications and guides were issued in April 2016 by the ICH and the FDA, followed by a May 13 ICH "teleconference to discuss the guidance and any questions and clarifications needed."
After revision: An additional The ICH and the FDA released draft Implementation Guide was released in February 2015 Draft specifications and guides were issued in April 2016 , and on May 13 ICH "teleconference to discuss the guidance and any there was an"