Description
This guidance is intended to help sponsors of investigational new drug applications (INDs) and new drug applications (NDAs) evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs), design DDI studies, and determine how to communicate DDI study results and risk mitigation strategies in labeling to address potential risks associated with increased or decreased exposure of COCs.
Scope & Applicability
Product Classes
2evaluate the drug-drug interaction (DDI) effects of their investigational drugs on combined oral contraceptives (COCs); Subject of the clinical drug interaction studies guidance; Subject of the drug interaction studies
Additional protection such as condoms
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
4The interval within which a change in systemic exposure is considered not clinically significant.
Pharmacokinetic parameter (AUC) derived from mass balance studies
Cmax may be more informative for safety
Property of a drug that causes developmental toxicity
Identified Hazards
Hazards
2evaluate the drug-drug interaction (DDI) effects
Risk of causing developmental malformations
Related CFR Sections (1)
- 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 (3)
- Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Status: Draft)
- QTc Information in Human Prescription Drug and Biological Product Labeling: Draft Guidance for Industry (Status: Draft)
- Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (Status: Draft)