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Drug safety is the work of making sure medicines are tested, approved, and monitored so that their benefits outweigh their risks. It covers clinical trials, the approval process, warning letters, recalls, and reporting of side effects. The Food and Drug Administration leads this work, alongside drug makers, researchers, health care providers, and patients.

People usually ask how a drug gets approved and what happens when problems appear after it is on the market. They want to know how to report a side effect, how fast-track paths work, how supplements differ from drugs, and how safety claims should be judged.

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September 16last updated

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Latest in Drug Safety

Food and Drug Administration

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How the FDA’s 1995 Approval of OxyContin Contributed to America’s Opioid Crisis

In December 1995, the U.S. Food and Drug Administration made a decision that would trigger decades of addiction, overdose, and death across America. The…

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Emergency Use Authorization: The FDA’s Crisis Playbook

When COVID-19 vaccines rolled out across America in December 2020, most people didn't realize they were receiving products that hadn't received full FDA approval.…

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Understanding FDA Warning Letters and Safety Alerts

The Food and Drug Administration issues thousands of enforcement actions each year, from formal warning letters to urgent product recalls. These documents offer a…

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How Dietary Supplements Can Be Sold Without FDA Approval

The dietary supplement industry represents one of the biggest paradoxes in American healthcare. It's a massive market that has exploded from 4,000 products in…

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Reporting Drug and Medical Device Problems to the FDA

When the FDA approves a new drug or medical device, it has passed rigorous safety tests. But those clinical trials only tell part of…

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Generic Drugs: Why 90% of Prescriptions Are Copies (And Why That’s Good)

Nine out of every ten prescriptions filled in America are for generic drugs. These medications save the U.S. healthcare system $408 billion annually, yet…

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How the FDA Decides Which Drugs You Can Buy

Getting a new medicine from a laboratory to your pharmacy involves one of the most demanding regulatory gauntlets in the world. The U.S. Food…

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Understanding Antibiotic Resistance

Antibiotics are failing. The miracle drugs that saved countless lives and made modern medicine possible are losing their power against an enemy that evolves…

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