<searchTitle>Drug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Availability; Federal Register Vol. 89, Issue </searchTitle>
<granuleClass>NOTICE</granuleClass>
<accessId>2024-24442</accessId>
<agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
<agency order="2">Food and Drug Administration</agency>
<commentDate>2025-01-21</commentDate>
<departmentDoc>Docket No. FDA-2024-D-3903</departmentDoc>
<billingCode>4164-01-P</billingCode>
<frDocNumber>2024-24442</frDocNumber>
<action>Notice of availability.</action>
<summary>The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug Interaction Information in Human Prescription Drug and Biological Product Labeling." The draft guidance is intended to assist applicants in developing the DRUG INTERACTIONS section of labeling as described in FDA regulations for the content and format of labeling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 The purpose of the draft guidance is to provide recommendations on what information to include in, and how to present and organize the information within, the DRUG INTERACTIONS section of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.</summary>
<dates>Submit either electronic or written comments on the draft guidance by January 21, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.</dates>
<contact>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.</contact>
<tocSubject1>Guidance</tocSubject1>
<tocDoc>Drug Interaction Information in Human Prescription Drug and Biological Product Labeling Content and Format, </tocDoc>
<urlRef>https://www.fda.gov/CYPandTransporterInteractingDrugs</urlRef>
<urlRef>https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</urlRef>
<urlRef>https://www.fda.gov/regulatory-information/search-fda-guidance-documents</urlRef>
<urlRef>https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</urlRef>
<urlRef>https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</urlRef>
<urlRef>https://www.regulations.gov</urlRef>