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 Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA, or ANDA
This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA)