Description
This guidance is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. This guidance provides recommendations to help ensure that clinically relevant information on QTc interval prolongation is included in and distributed appropriately across sections of labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling.
Scope & Applicability
Product Classes
3guidance 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
directed against aggregated forms of amyloid beta
Stakeholders
2Entity submitting development data and knowledge; Entity performing the work process for change
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2Characteristic of drugs requiring cardiac repolarization assessment
Severity criteria for dosage modification
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)
- Clinical Pharmacology Considerations for Peptide Drug Products (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)
- Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements (Status: Final)
- Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Final)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (Status: Final)