An FDA mechanism that permits the use of unapproved medical products—or unapproved uses of approved products—during declared public health emergencies when no adequate approved alternatives are available. EUAs are faster than standard approval but require a lower evidence threshold, typically demonstrating that known and potential benefits outweigh known and potential risks.

EUAs became widely known during the COVID-19 pandemic for vaccines and therapeutics. In the peptide context, EUAs represent the regulatory mechanism that could theoretically accelerate access to promising peptide therapeutics during future public health emergencies. The EUA framework also illustrates the FDA’s capacity for flexible regulatory approaches when urgency warrants it—a point sometimes raised in debates about peptide access and the pace of drug approval.