federal_register: 2025-21798

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2025-21798 QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "QTc Information in Human Prescription Drug and Biological Product Labeling." This guidance is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. The guidance provides recommendations on how and where to appropriately include the clinically relevant information on QTc interval prolongation in the labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling. This guidance finalizes the draft guidance of the same title issued on August 8, 2023. 2025-12-03 2025 12 https://www.federalregister.gov/documents/2025/12/03/2025-21798/qtc-information-in-human-prescription-drug-and-biological-product-labeling-guidance-for-industry https://www.govinfo.gov/content/pkg/FR-2025-12-03/pdf/2025-21798.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 guidance for industry entitled "QTc Information in Human Prescription Drug and Biological Product Labeling." This guidance is intended to assist applicants with...  

Links from other tables