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: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
FDA is issuing this guidance document to describe the technical and scientific information that FDA expects in a marketing application for a pen, jet, or related injector device that is intended to be used with a drug or biological product