FDA Issues Guidance Setting Goal of SPL Implementation by Fall 2005

Manufacturers should begin submitting electronic labeling changes for previously approved drugs in structured product labeling (SPL) format by fall 2005, according to a final FDA guidance.

The FDA currently accepts labeling changes in both PDF and SPL format, but the agency's goal is to transition exclusively to SPL, which provides numerous advantages over PDF format, including increased flexibility and compatibility across different computer operating systems.

Under the "Providing Regulatory Submissions in Electronic Format -- Content of Labeling" final guidance, drugmakers should switch to SPL format by this fall for all labeling submissions for approved products. The agency didn't establish a transition date for labeling submissions for unapproved drugs.

To view the final guidance on SPL submissions, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0041-gdl0002.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0041-gdl0002.pdf).