FDA electronic-submissions workshop

The Food and Drug Administration’s Center for Tobacco Products (CTP), is due to hold a one-day workshop to obtain public input on ‘topics related to the potential electronic submission of tobacco product applications and other information’.

The workshop will focus on the technical aspects of electronic submissions, including potential standards for content, format, and structure.

According to an FDA press note, the input from the public workshop might ‘assist the Agency in the potential development and implementation of an electronic submission standard for CTP’.

At the same time, the FDA is opening a public docket to receive comments on this topic.

Registration for the workshop is open until June 21; the workshop is due to be held on July 18; and comments directed to the docket have to be received by August 19.

More information is at:

http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-3973.