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: Drug Products, Including Biological Products, that Contain Nanomaterials

Origin/Publisher:

FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588857.pdf

Content:
This document provides guidance on the development of human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form.

Go back

GMP Conferences by Topics