federal_register: E8-5083

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
E8-5083 Draft Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims." This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. Because blood pressure control is well established as beneficial in preventing serious cardiovascular events, FDA believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling. This draft guidance is intended to recommend standard labeling for antihypertensive drugs except where differences are clearly supported by clinical data. 2008-03-13 2008 3 https://www.federalregister.gov/documents/2008/03/13/E8-5083/draft-guidance-for-industry-on-hypertension-indication-drug-labeling-for-cardiovascular-outcome https://www.govinfo.gov/content/pkg/FR-2008-03-13/pdf/E8-5083.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims." This draft guidance is intended to assist applicants in...  

Links from other tables