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FDA reviews informed consent regulation

The regulation allows the conduct of research studies to test emergency treatments on patients with specific life-threatening medical conditions, such as head trauma, cardiac arrest and stroke, when

Salix’ Colazal gets extended exclusivity

The company received the extended exclusivity after the FDA accepted for review a clinical package submitted by the company which contained data about the use of Colazal in

FDA rejects Epix’ Vasovist appeal

Epix submitted the appeal to the FDA’s Office of New Drugs (OND) on June 30, 2006 in response to two prior approvable letters for Vasovist. Epix were also