federal_register: 2020-25744

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2020-25744 Clinical Drug Interaction Studies With Combined Oral Contraceptives; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Drug Interaction Studies With Combined Oral Contraceptives." This guidance assists sponsors of investigational new drug applications and new drug applications in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs) during drug development as well as determining how to communicate the results and recommendations from the DDI studies. Specifically, this guidance focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug on a COC, including the need for and design of the clinical studies and the interpretation of the study results. 2020-11-23 2020 11 https://www.federalregister.gov/documents/2020/11/23/2020-25744/clinical-drug-interaction-studies-with-combined-oral-contraceptives-draft-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2020-11-23/pdf/2020-25744.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Drug Interaction Studies With Combined Oral Contraceptives." This guidance assists sponsors of investigational new drug...

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