GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims

OMB 0910-0670

The information supports Agency guidance intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. 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.

The latest form for GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims expires 2022-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0670 GFI Hypertension Indication SSA 2019.pdf Supporting Statement A
Cardiovascular Outcome Claim Supplement Submission Other-Agency Guidance
Submission to Docket Number FDA-2008-D-0150 Other-Guidance

All Historical Document Collections

201911-0910-010 Approved without change	Extension without change of a currently approved collection	2019-12-05
201610-0910-011 Approved without change	Extension without change of a currently approved collection	2016-11-08
201309-0910-001 Approved without change	Extension without change of a currently approved collection	2013-09-10
201007-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	2010-07-26

OMB Details

Submission to Docket Number FDA-2008-D-0150

Federal Enterprise Architecture: Health - Consumer Health and Safety