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Notice. "Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability" Federal Register 89, no. 204 (October 22, 2024): 84353-84354. https://www.govinfo.gov/app/details/FR-2024-10-22/2024-24442.
Office of the Federal Register, National Archives and Records Administration. (). 89 FR 84353 - Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability. [Government]. Office of the Federal Register, National Archives and Records Administration. https://www.govinfo.gov/app/details/FR-2024-10-22/2024-24442
Office of the Federal Register, National Archives and Records Administration. 89 FR 84353 - Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability. Office of the Federal Register, National Archives and Records Administration, , https://www.govinfo.gov/app/details/FR-2024-10-22/2024-24442
Office of the Federal Register, National Archives and Records Administration, Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability, govinfo, (October 22, 2024), https://www.govinfo.gov/app/details/FR-2024-10-22/2024-24442.
Close xFederal Register Volume 89, Issue 204 (October 22, 2024)
Regulatory Information
Federal Register
AE 2.7:
GS 4.107:
AE 2.106:
Office of the Federal Register, National Archives and Records Administration
Notices
Notice of availability.
Submit either electronic or written comments on the draft guidance by January 21, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Joseph Grillo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0591; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug Interaction Information in Human Prescription Drug and Biological Product Labeling." The draft guidance is intended to assist applicants in developing the DRUG INTERACTIONS section of labeling as described in FDA regulations for the content and format of labeling for human prescription drug and biological products. The purpose of the draft guidance is to provide recommendations on what information to include in, and how to present and organize the information within, the DRUG INTERACTIONS section of labeling for human prescription drug and biological products to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
84353-84354
89 FR 84353
Docket No. FDA-2024-D-3903
2024-24442