brief summary
- Guideline or reference source
- FDA www.fda.gov
- Definition
- This is the technical name for the detailed information that appears in ads for prescription drugs. The law requires that print ads making claims about a drug (product claim ads) include a "brief summary" with all the risks listed in the drug's "prescribing information" and at least one FDA-approved use of the drug. The brief summary generally includes: Who should not take the drug; When the drug should not be taken; Possible serious side effects of the drug and, if known, what can be done to lower the chance of having them; Frequently occurring, but not necessarily serious, side effects. The "brief summary" includes a lot of information, so it is usually presented on its own page of a print ad. When the "brief summary" is part of an ad directed at the consumer, the FDA encourages drug companies to use language consumers can easily understand.
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