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GUIDANCE DOCUMENT

Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA Draft Guidance for Industry and Food and Drug Administration Staff April 2020

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-5573
Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center 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.


Submit Comments

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:

Dockets Management
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.

Questions?

Contact Point
Combination Products Guidance Contact
Office of Combination Products
combination@fda.gov
301-796-8930
301-847-8619
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