Identification of Need: The need for an EUA is identified based on the severity and scope of the public health emergency. Data Submission: Manufacturers submit data on the safety and efficacy of the product. This data may be less comprehensive than what is required for full approval but must demonstrate that the product’s benefits outweigh its risks. Review and Decision: Regulatory agencies review the submitted data and assess the product's potential impact on public health. If the criteria are met, an EUA is granted.
