What it means
The US government agency that decides whether a drug, vaccine or medical device is safe and effective enough to be sold, oversees drug labeling, and watches for problems after approval. It can add a boxed warning (its strongest warning) to a drug's label or order a recall. It also regulates food safety, cosmetics and tobacco products. Clinicians and the public report drug side effects to it through MedWatch.
For the nurse
Report a serious or unexpected drug reaction through the facility's process; reports may go on to the FDA.
At a glance
| Also written | Food and Drug Administration, U.S. Food and Drug Administration |
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Related terms
side effect
An effect of a drug, other than the one it is given for, that is known and expected to happen in some people.
adverse effect
An unwanted and harmful effect of a drug or treatment given at a normal dose.
Centers for Disease Control and Prevention
The United States government agency that studies disease and sets national guidance on preventing and controlling it.