Esta tradução está a ser preparada. Entretanto, mostramos temporariamente a versão original em inglês.
Negócios · 03/04/20131 min de leitura
Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement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
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry and FDA staff entitled "Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization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.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →