In 2006 the Food and Drug Administration overhauled drug labeling and created a new section called “Highlights.” See 21 C.F.R. § 201.57(a) (specifying highlights section requirements). Such highlights must include “[a] concise summary of any boxed warning.” §201.57(a)(4). With respect to all other warnings, contraindications, and adverse reactions, the highlights regulation provides:
(9) Contraindications. A concise statement of each of the product’s contraindications, as required under paragraph (c)(5) of this section, with any appropriate subheadings.
(10) Warnings and precautions. A concise summary of the most clinically significant information required under paragraph (c)(6) of this section, with any appropriate subheadings, including information that would affect decisions about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug, and measures that can be taken to prevent or mitigate harm.
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