FDA Guidance for Industry: Indexing Structured Product Labeling
Title:
FDA Guidance for Industry: Indexing Structured Product Labeling
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072317.pdf
Content:
This guidance explains that FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will index the content of labeling for human drug and biological products using SPL (Structured Product Labeling).