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Emergency Use Authorization vs. Full FDA Approval: What You Need to Know

Nov 02, 2021
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Understanding the differences between an Emergency Use Authorization (EUA) and full FDA approval is very important when making the most informed decisions for your family.

What Is the FDA?

The United States Food and Drug Administration (FDA) is a federal agency whose purpose is to protect people by making sure products like medicines, medical devices, food, and cosmetics are safe. In 1937, 100 people died because a drug contained an unsafe ingredient. At that time, there was no agency to make sure drugs were safe. One year later, Congress passed the Food, Drug, and Cosmetic Act (FDCA), establishing the FDA and requiring that medications be proven safe before marketing to patients.

What Is FDA Approval?

Before medicines are approved, they have to go through pre-clinical trials in animals to provide evidence of safety. Before trials can begin in humans, an Investigational New Drug (IND) application must be filed with the FDA.

If the FDA grants the IND, clinical trials may begin. Healthy people volunteer for phase 1 clinical trials to determine medication safety and dosing. A larger group of volunteers is used for phase 2 clinical trials intended population to assess safety and to make sure the medication works the right way. An even larger group of volunteers is chosen for phase 3 clinical trials to review safety, the effectiveness of the medicine, and any side effects.

After the drug has passed the three phases of clinical trials a New Drug Application (NDA) or Biologics License Application (BLA) is submitted to the FDA for approval. If the drug is approved after a review of the NDA or BLA, safety monitoring is completed through the FDA MedWatch program where the general public can report side effects. Vaccines have a similar reporting program called the Vaccine Adverse Event Reporting System (VAERS).

What Is an Emergency Use Authorization (EUA)?

During a public health emergency, an EUA allows the FDA to make approved and unapproved medical supplies and medications (including vaccines and treatments) available. For emergency medical supplies and medications that have not been approved for use, the FDA allows the use of these products for the diagnosis, treatment, and prevention of life-threatening medical conditions and disease if the product meets certain criteria.

The FDA requires safety and effectiveness data to review an EUA. The FDA reviews medical records, site visits for manufacturing facilities, previous compliance history, and compliance with good manufacturing practices to ensure safety post-EUA. The FDA looks at the risk versus the benefit of waiting for all the evidence needed for full approval. The FDA does not allow the use of a test, medical supply, or medication if they do not think it is safe.

The FDA website has more information on the FDA approval process and Emergency Use Authorization.

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700 Children’s® features the most current pediatric health care information and research from our pediatric experts – physicians and specialists who have seen it all. Many of them are parents and bring a special understanding to what our patients and families experience. If you have a child – or care for a child – 700 Children’s was created especially for you.