Emergency Use Authorizations by the FDA: Why and How
Emergency Use Authorizations (EUAs) are critical in getting life-saving medicines to patients as quickly as possible. They’ve proven useful in the face of pandemics like COVID-19. The EUA was enacted when Section 564 of the Federal Food, Drug, and Cosmetic Act was changed by the Project BioShield Act in 2004, following a USFDA initiative. The FDA has implemented this programme to protect public health by ensuring the safety, efficacy, and quality of medical products while also responding to medical emergencies and emerging public health hazards.
Let’s look at it in more detail in the following lines.
Understanding the EUA
The EUA channel is designed to make medical countermeasures more accessible during declared emergencies. In such cases, the FDA Commissioner may permit the following:
• The use of unapproved medical goods is permitted.
• Using approved medicinal items without permission.
Vaccines, IV fluids, medications, equipment, diagnostics, and other products covered by the EUA can be used to diagnose, treat, or prevent life-threatening illnesses. If the following criteria are met, a product is granted EUA:
• Proof of a life-threatening sickness or condition.
• The scientific evidence shows that the product is effective for its intended purpose, and that the benefits exceed the dangers (aka evidence of safety).
• A scarcity of alternatives.
Sponsors should familiarise themselves with the FDA’s standards ahead of time so that they can follow the best regulatory process and submit an EUA without errors. The sponsor must provide the following mandatory information in the application.
The Sponsor must submit data to the FDA for an EUA approval.
• An explanation of the product and the use to which it is meant.
• The product’s FDA approval status.
• Information on safety and efficacy, such as clinical and non-clinical data, etc.
• A report on risk-benefit analysis.
• Information on chemistry, manufacturing, and controls (CMC).
• Information for the distribution of the medical product in issue, including dose, contraindications, warnings, and adverse occurrences.
How does the FDA issue EUAs?
In summary, below is a diagrammatic representation of the EUA lifecycle:
The EUA is usually granted for a short time and then terminated by the FDA after the emergency has passed.
COVID-19 and EUA
COVID-19 was declared a pandemic by the Secretary of Health and Human Services (HHS) on January 31, 2020. Since then, the FDA has played a key role in the approval of a few vaccinations and home test kits via the EUA pathway to combat the global pandemic.
With the advent of new COVID-19 variations, the pharmaceutical sector as a whole is working hard to slow the spread and reduce fatality rates. Novel pharmaceutical goods are needed, as well as faster approvals by worldwide regulatory authorities, to minimise time to market. According to experts, the EUA process for registering new medicinal products/drugs is the way to go. The European Medicines Agency (EMA), the Central Drugs Standard Control Organization (CDSCO), the Saudi Food and Drug Authority (SFDA), and others have all implemented the EUA pathway for speedier approvals.
If you’re a pharmaceutical company looking for an EUA for a life-saving product, you’ll need the help of an experienced regulatory solutions supplier. Contact Freyr for a more efficient time-to-market and a compliance path.
Category: Pharmaceuticals, Market Access
Key Words: Pharmaceuticals, Regulatory Affairs, Emergency Use Authorization, EMA, USFDA, COVID-19, CDSCO, SFDA
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