federal_register: 2020-26510

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2020-26510 Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications." This draft guidance focuses on specific recommendations pertinent to gastric pH- dependent drug-drug interaction (DDI) assessment and describes the FDA's recommendations regarding when clinical DDI studies with acid- reducing agents (ARAs) are needed; design of the clinical studies; interpretation of study results; and communicating findings and options for managing pH-dependent DDIs in product labeling. 2020-12-01 2020 12 https://www.federalregister.gov/documents/2020/12/01/2020-26510/evaluation-of-gastric-ph-dependent-drug-interactions-with-acid-reducing-agents-study-design-data https://www.govinfo.gov/content/pkg/FR-2020-12-01/pdf/2020-26510.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical...

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