Clinical Drug Interaction Studies With Combined Oral Contraceptives; Guidance for Industry; Availability
What this record is not
Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Clinical Drug Interaction Studies With Combined Oral Contraceptives." This guidance is intended to help sponsors of investigational new drug applications and new drug applications evaluate the need for drug-drug interaction (DDI) studies with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and risk mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. The guidance finalizes the draft guidance "Clinical Drug Interaction Studies With Combined Oral Contraceptives" issued on November 23, 2020.
Abstract as published in the Federal Register.
READ THE FULL DOCUMENT
The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.
View on federalregister.gov →That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.
Create a free account