This post was written by Jennifer Pike.

The FDA released draft guidance on January 3, 2012 entitled Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using eCTD Specifications. The guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act, which amended to Federal Food, Drug, and Cosmetic Act to require that certain regulatory submissions be submitted in electronic format. The guidance describes how FDA plans to implement this requirement. According to the guidance, requirements for electronic submission will be phased in on the following schedule: (1) 24 months after publication of the final version of this draft guidance, the requirements will apply to new drug application (NDA), abbreviated new drug application (ANDA), and biologics license application (BLA) submissions, and (2) 36 months after publication of the final guidance, the requirements will apply to investigational new drug application (IND) submissions. Comments will be accepted until March 4, 2013. A second draft guidance document, Providing Submissions in Electronic Format – Summary Level Clinical Site Data for CDER’s Inspection Planning, is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the individual study site level. Such datasets facilitate the use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. The guidance describes a recommended electronic format for the datasets to be submitted voluntarily in NDA, BLA, and NDA and BLA supplemental applications submitted to CDER. Comments may be submitted to www.regulations.gov by February 19, 2013.