GFI: Hypertension Indication; Drug Labeling for Cardiovascular Outcome Claims

OMB 0910-0670

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.

OMB Details

Submission to Docket Number FDA-2008-D-0150

Federal Enterprise Architecture: Health - Consumer Health and Safety


© 2021 OMB.report | Privacy Policy