Author: [AUTHOR] Published on 10/25/2024 12:00:00 AM
FDA Announces Availability of a Draft Guidance on Drug Interaction Information in Product Labeling
On October 22, 2024, the US Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling. This draft guidance is intended to assist applicants in developing the DRUG INTERACTIONS section of the Prescribing Information labeling as described in FDA’s regulations for the content and format of labeling for human prescription drug and biological products (21 CFR 201.56(a) and (d) and 201.57(c)(8)). Prescription drug labeling must contain a summary of the essential information necessary for safe and effective use of the drug and is a primary tool for the FDA to communicate drug interaction information to healthcare practitioners. Effective communication of drug interaction information informs the optimal use of the drug and the healthcare practitioner’s clinical decision-making (e.g., prescribing decisions or management instructions).
The draft guidance provides recommendations on what information to include in, and how to present and organize the information within, the DRUG INTERACTIONS section of prescription drug labeling to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.
Please refer to the
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling draft guidance for more details. FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No. FDA-2024-D-3903) available at
https://www.regulations.gov up to 90 days following publication in the FEDERAL REGISTER. This guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience and make your voice count.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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