FDA Guidances & Information

Find reliable drug guidance, compliance and regulatory information from the resources below.

View FDA Structured Product Labeling Resources

The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Find resources on industry data standards for SPL from the FDA.

View FDA Drug Labeling Guidances

View the FDA's listing of Labeling Guidances.

View All FDA Drug Guidances

Guidance documents represent the FDA's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. Another method of obtaining guidance documents is through the Division of Drug Information.