Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA Draft Guidance for Industry and Food and Drug Administration Staff April 2020
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of the Commissioner, Office of Clinical Policy and Programs, Office of Combination ProductsCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
This guidance covers emergency-use injectors submitted under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA). The term “emergency-use injector” means injectors marketed with an emergency-use drug as a prefilled single entity combination product under 21 CFR 3.2(e)(1) or as a co-packaged combination product under 21 CFR 3.2(e)(2). Emergency-use injector includes pen injectors, autoinjectors, or on-body-wearable delivery systems for drugs for emergency treatment of conditions such as anaphylaxis, opioid overdose, poisoning, or severe hypoglycemia.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2019-D-5573.