13 June 2012
US FDA Scheduled the meeting: Update to Electronic Common Technical Document Module 1
The US Food and Drug Administration (FDA) has announced meeting to update and discuss the new version of the eCTD Module 1 document. The purpose of this meeting is to provide clarification and answer questions from industry and software vendors regarding the changes being made to the module 1 by FDA.
Date and Time of meeting: 18th September 2012 (Tuesday) from 8 a.m. to 11:30 a.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Great Room 1503, Silver Spring, MD, 20993.
Registration Limit: only 350.
Registration Process: Need to send registration information including name, title, firm name, address, telephone, and fax number to Julie Quinonez.
Contact Information: Julie Quinonez,
Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1135,
Silver Spring, MD, 20993,
301-796-0282, FAX: 301-796-9876,email: Julie.Quinonez@fda.hhs.gov