FDA Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4
Title:
FDA Guidance for Industry and FDA Staff - Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4
Origin/Publisher:
FDA, http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM346181.pdf
Content:
This guidance identifies additional, technical information that should be submitted by sponsors who seek to rely on conformity to ISO 11040-4 for a glass syringe product.