The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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).

Go back

GMP Conferences by Topics