Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry and FDA staff entitled "Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4." These supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with the ISO 11040-4 standard when connected to devices ("connecting devices") that comply with the ISO 594-2 standard.