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.
Approved without change |
Extension without change of a currently approved collection | 2019-12-05 | |
Approved without change |
Extension without change of a currently approved collection | 2016-11-08 | |
Approved without change |
Extension without change of a currently approved collection | 2013-09-10 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2010-07-26 |
Federal Enterprise Architecture: Health - Consumer Health and Safety