The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective | FDA

The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective | FDA

The FDA is working to address the coronavirus disease 2019 (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about FDA-approved drugs, emergency use authorizations and potential treatments during a public health emergency.

Q: What does it mean to be an FDA-approved drug?

A: FDA approval of a drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. The drug approval process takes place within a structured framework that includes collecting clinical data and submitting an application to the FDA. Learn more about the FDA’s Drug Review Process.

Q: What is an emergency use authorization and how is it being used to respond to COVID-19?

A: In certain types of emergencies, the FDA can issue an emergency use authorization, or EUA, to provide more timely access to critical medical products (including medicines and tests) that may help during the emergency when there are no adequate, approved, and available alternative options.

The EUA process is different than FDA approval, clearance, or licensing, because the EUA standard may permit authorization based on significantly less data than would be required for approval, clearance, or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria within weeks, rather than months to years.

EUAs are in effect until the emergency declaration ends. But they can be revised or revoked as we evaluate the needs during the emergency and new data on the product’s safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA.

• Learn more about EUAs in this video
• Read more about COVID-19 tests
• Find a community-based testing site

Q: What is the FDA’s role in regulating potential treatments during a public health emergency?

A: The FDA carries out many activities to protect and promote public health during a public health emergency, including helping to accelerate the development and availability of potential treatments, protecting the security of drug supply chains, providing guidance to food and medical device manufacturers, advising developers on clinical trial issues, and keeping the public informed with authoritative health information.

The FDA is committed to supporting the development of new drugs, and the potential repurposing of existing drugs, to address COVID-19 by working with potential drugmakers and sponsors to rapidly move products into clinical trials, while helping to ensure that trials are properly designed and safe.

Read more about FDA efforts to accelerate treatments and other actions related to coronavirus.