The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products.

Impact of MMX® mesalamine on improvement and maintenance of health-related quality of life in patients with ulcerative colitis.

Background: Ulcerative colitis (UC) substantially reduces patients' health-related quality of life (HRQoL). The current study examined the burden of disease and the impact of daily multimatrix (MMX®) mesalamine treatment on HRQoL for patients with active or quiescent mild-to-moderate UC.

Methods: Data were from a two-phase, multicenter, open-label study with mild-to-moderate UC patients.

The impact of MMX mesalazine on disease-specific health-related quality of life in ulcerative colitis patients.

Background: Past studies with ulcerative colitis (UC) patients indicate that disease activity strongly predicts health-related quality of life (HRQL).

Aim: To examine the degree to which daily treatment with MMX mesalazine predicts improved HRQL for patients with active UC and with stable HRQL for patients with quiescent UC.

Methods: Data from two phases of a multicentre open-label trial were examined.

MMX Mesalamine for Induction and Maintenance Therapy in Mild-to-Moderate Ulcerative Colitis.

Two 8-week, randomized, placebo-controlled parent studies, SPD476-301 (by Lichtenstein and associates) and SPD476-302 (by Kamm and colleagues), of MMX Multi Matrix System (MMX) mesalamine have evaluated the induction of remission in ulcerative colitis patients, and a third study has evaluated the maintenance of remission in patients from these parent studies. Here, we examine data only from patients who received MMX mesalamine 2.4 g or 4.

Effect of preoperative intravenous pantoprazole in elective-surgery patients: a pilot study.

Background: This study evaluated the effects of intravenous pantoprazole on gastric volume and acid output in elective-surgical patients.

Methods: This is a multicenter, randomized, pilot study of adult patients receiving intravenous pantoprazole: 40 mg every 24 h, 40 mg every 12 h (q12h) or 80 mg q12h. The first dose was administered 1 h before general anesthesia for surgery.