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The Pharma Marketing Glossary
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Brief Summary

Similar or Alternative Terms Meaning the Same Thing n/a
Related Term(s) Direct-to-Consumer Advertising (DTCA), Major Statement, Adequate Provision, Important Safety Information (ISI)

Definitions

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The "brief summary" includes all the risk information about a prescription drug and is generally based on the prescribing information. The brief summary may leave out non-risk information, such as the chemical description of the drug, how it works in the body, and directions for using it. For direct-to-consumer (DTC) ads, FDA recommends that brief summaries be written in language that consumers can understand.

"Brief Summary" 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. The brief summary may leave out non-risk information, such as the chemical description of the drug, how it works in the body, and directions for using it.

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