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.

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Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-5573.

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