Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format

Description

This guidance is intended to assist applicants and reviewers in drafting the WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, and BOXED WARNING sections of labeling, as described in the final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (21 CFR 201.56 and 201.57). The recommendations in this guidance are intended to help ensure that the labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.

Scope & Applicability

Regulatory Context

• 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

  (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →

• 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .

  The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →

• 21CFR312.32§ 312.32 IND safety reporting.

  (a) Definitions. The following definitions of terms apply to this section:Read full regulation →

• 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.

  (a) Definitions. The following definitions of terms apply to this section:Read full regulation →

• 21CFR314.520§ 314.520 Approval with restrictions to assure safe use.

  (a) If FDA concludes that a drug product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the drug product, such as:Read full regulation →

• 21CFR601.42§ 601.42 Approval with restrictions to assure safe use.

  (a) If FDA concludes that a biological product shown to be effective can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to assure safe use of the biological product, such as:Read full regulation →

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