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Draft Guidance for Industry Session
Draft Guidance for Industry: Labeling for outcome claims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
Bibliography