FDA Answers Questions From ACE Webinar, Says ACE Requirements 'Outlined'

The Food and Drug Administration considers its Automated Commercial Environment filing requirements to be “outlined,” according to a list of questions and answers posted by Integration Point following a Dec. 10 webinar (see 1512110027). Responding to a question on whether the agency’s required data elements are “locked down,” FDA said “any additional updates are refinements or clarifications, until such a time that new regulatory requirements indicate the need for further changes,” according to Integration Point, which hosted the webinar. The Q&A also includes information on the FDA ACE pilot, DUNS numbers, FDA’s “lockdown” policy of no changes to entry data within five days of arrival, and foreign-trade zones, among other topics.