SPL Now "Only Acceptable" Format for CBER Original Submissions

Rockville, MD (Oct. 15)-According to a July 11, 2008 memorandum posted by FDA's Center for Biologics Evaluation and Research (Docket FDA-1992-S-0039), starting Oct. 15, Health Level 7 (HL7) structured product labeling (SPL) in XML (extensible markup language) will be the only acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive. The deadline applies only to the content of labeling with original submissions, supplements, and annual reports.

The agency encourages applicants to submit content according the July 2008, FDA Draft Guidance Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing, available here.

Moreover, FDA will hold a public workshop on Nov. 17 in Rockville, Maryland, to provide the biologics industry guidance on submitting content of labeling in SPL format. FDA will also present an overview of the agency’s voluntary pilot program for electronic submission of drug establishment registration and drug listing information.