Description
This guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of drug interaction (DI) information in labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. The purpose of this guidance is to provide recommendations to help ensure that appropriate DI information is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners (HCPs) and includes content that guides the safe and effective use of the drug.
Scope & Applicability
Product Classes
4guidance applies to drugs regulated under section 505
Regulated under section 351(i) of the PHS Act; Virus, therapeutic serum, toxin, vaccine, or protein applicable to prevention or treatment; Alternative regulation category for products meeting device definition
Proteins that reduce proinflammatory cytokines and affect CYP enzyme expression
Example of a drug class known for specific interactions
Stakeholders
5ensure information is clear and accessible to HCPs
Entity submitting development data and knowledge; Entity performing the work process for change
Healthcare professionals who reference labeling and public resources
Entities submitting supplements to BLAs
The target audience for labeling information.
Regulatory Context
Attributes
3Threshold for including drug interaction information in labeling.
Cmax may be more informative for safety
AUC or Cmin may correlate with efficacy
Identified Hazards
Hazards
3Example of a specific clinical effect from a DI
Potential safety issue from drug interactions
Clinically significant outcome of a drug interaction
Related CFR Sections (2)
- 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 →
See Also (8)
- Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)
- Clinical Pharmacology Considerations for Peptide Drug Products (Status: Draft)
- Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (Status: Final)
- Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)