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Food and Drug Administration

Cardiovascular and Renal Drugs Advisory Committee

April 26, 2006

Briefing Information

Food and Drug Administration

Briefing Document

8:00 AM – 12:00 PM Session:

The committee will discuss the agency’s draft recommendations for relabeling of antihypertensive drugs for outcome claims, as a follow-up to the committee’s meeting on June 15, 2005, where the committee discussed class labeling of antihypertensive drugs based on the proximity of their data to outcome trials

Questions to the Committee – Draft Guidance for Industry Session

Draft Guidance for Industry: Labeling for outcome claims for drugs to treat hypertension

Food and Drug Administration

Briefing Document

1:00 PM – 5:00 PM Session:

The committee will discuss the “Placebo in Hypertension Adverse Reaction Meta-Analysis” (PHARM) Study, a meta-analysis of more than 80,000 patients in placebo-controlled trials of antihypertensive medications, which evaluated the risk of irreversible harm in conducting placebo-controlled trials in patients with hypertension

Questions to the Committee – PHARM Study Session


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