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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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All written comments should be identified with this document's docket number: FDA-2023-D-2482
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthOncology Center of Excellence
This guidance describes how FDA intends to apply its drug labeling authorities to certain software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug or a prescription drug-led, drug-device combination product (hereafter referred to as a “combination product”) that is assigned to the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as the lead center. This guidance expands on and was developed in response to comments submitted in response to the Federal Register notice “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments" (83 FR 58574 (November 20, 2018)).