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FDA Approves First COVID-19 Vaccine

On August 23, 2021, the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, for the prevention of COVID-19 disease in individuals 16 years of age and older.

FDA COVID-19 RESPONSE

FDA is working with U.S. government partners, including CDC, and international partners to address the pandemic.

Products We Regulate

Featured Topics

New Era Feature

New Era of Smarter Food Safety

A new approach to food safety that recognizes and builds on the progress made in the past but looks towards what processes and tools will be needed for the future.
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Fostering Drug Competition

Increasing the availability of generic drugs helps to create competition in the marketplace, helping make treatment more affordable and increasing access to healthcare for more patients.
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Combating the Opioid Crisis

FDA takes actions to combat prescription opioid abuse.

Recent Press Announcements

Newsroom Meetings Testimony Speeches

Recalls, Market Withdrawals, & Safety Alerts

The FDA provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this website

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FDA VOICES: PERSPECTIVES FROM FDA EXPERTS

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FDA Continues Collaboration with Drug Compounders as Second Anniversary of Compounding Quality Center of Excellence Approaches

The Compounding Quality Center of Excellence works with outsourcing facilities, pharmacy compounders to improve the quality of compounded prescription drugs.
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FDA’s National Center for Toxicological Research Celebrates Half a Century of Cutting-Edge Research

NCTR is celebrating 50 years of scientific achievements including the groundbreaking research we have done—and continue to do—in support of the FDA’s mission.
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FDA Seeks Patient Insight: Call for Applications for the Patient Engagement Collaborative

The FDA is announcing the call for applications for the next cohort of the Patient Engagement Collaborative.

Recently Published Guidances

Resources and Programs

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