CRDAC

(redirected from Cardiovascular and Renal Drugs Advisory Committee)
AcronymDefinition
CRDACCardiovascular and Renal Drugs Advisory Committee
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References in periodicals archive ?
Members of the Cardiovascular and Renal Drugs Advisory Committee who supported approval agreed that the claim for dronedarone should be narrower than the primary end point in the ATHENA trial, which was defined as time to first event of cardiovascular hospitalization or death from any cause.
At a meeting of the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee, the panel voted 15-2 that data from four clinical trials demonstrated that rivaroxaban has a favorable risk-benefit profile for the proposed indication--the prophylaxis of venous thromboembolism, in patients undergoing hip or knee replacement surgery.
The FDA Cardiovascular and Renal Drugs Advisory Committee based its recommendation on review of data from the belatacept clinical development programme, which included more than 1,000 patients who received belatacept.
At a meeting this month, all nine voting members of the FDA's Cardiovascular and Renal Drugs Advisory Committee, agreed that prasugrel--a drug that was shown to be more effective than clopidogrel in preventing cardiovascular events, but with a higher rate of serious bleeding in a study of more than 13,000 patients with acute coronary syndromes (ACS)--had a favorable benefit-to-risk profile.
Granger was a consultant to AstraZeneca for the FDA's Cardiovascular and Renal Drugs Advisory Committee meeting in February; the panel unanimously recommended approval of Atacand for this population of patients on an ACE inhibitor.
At a meeting, the Cardiovascular and Renal Drugs Advisory Committee voted 7-0 in favor of approving the fixed-dose angiotensin receptor blocker--diuretic combination product as initial therapy.
This increased risk of serious angioedema was why the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee, in a 5-1 vote, recommended against approving the drug at a July meeting.
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