Department of Health and Human Services March 13, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Draft Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This draft guidance is intended to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension.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 This draft guidance is intended to recommend standard labeling for antihypertensive drugs except where differences are clearly supported by clinical data.
Privacy Act of 1974; Revision to Existing System of Records; Revised
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to alter the system of records for the C.W. Bill Young Cell Transplantation Program. This system of records is required to comply with the implementation directives of Public Law 109-129. Records are used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes. HRSA published in the Federal Register of August 17, 2007, a document concerning notice of a new system of records, 09-15-0068, C.W. Bill Young Cell Transplantation Program (FR. Doc. 07-4019). This document more fully explains the routine uses of records maintained in the system and amends the record retention and disposal policy. Accordingly, the notice is published below in its entirety, as amended.
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