^®: CRE Regulatory Action of the Week

FDA Seeks Comment on Draft Guidance for Providing Regulatory Submissions in Electronic Format
The U.S. Food and Drug Administration is seeking public comment on its Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications. The Draft Guidance describes how FDA plans to implement the requirements for the electronic submission of applications for certain human pharmaceutical products and is being issued for public comment. In its final form, this document will also supersede the guidance titled "Guidance for Industry Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications" that was issued in October 2005 and revised in April 2006 and June 2008. Written comments on the Guidance can be submitted at any time.

The FDA notice regarding this Draft Guidance is available at the following link until the notice is published in the Federal Register.