Regulatory and Drug Approvals News

An overwhelming majority of North Carolina voters - 89 percent - support food safety legislation that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick, according to a new poll commissioned by the Pew Health Group and conducted by Hart Research and Public Opinion Strategies.

An overwhelming majority of Ohio voters - 91 percent - support food safety legislation that would give the Food and Drug Administration (FDA) new authority to ensure the food Americans eat does not make them sick, according to a new poll commissioned by the Pew Health Group and conducted by Hart Research and Public Opinion Strategies.

Over the next several weeks, the U. S. Senate has an historic opportunity to take a major step toward improving food safety for all Americans.

Cequent Pharmaceuticals, a pioneer in the development of novel products to deliver RNAi-based treatments to prevent and treat human disease, has announced that it has filed its first IND (investigational new drug) application with the U.S. Food and Drug Administration (FDA).

The U.S. Food and Drug Administration has approved the use of CSL Limited's 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

The University of Rochester Medical Center (URMC) has announced the creation of a new center that will assist researchers studying the electrical activity of the heart with the goal of improving drug safety, understanding cardiac arrhythmias, and developing new electrocardiograph technologies. The Center for Quantitative Electrocardiology and Cardiac Safety - funded by a $2.

Sol-Gel Technologies announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel's Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients.

Nicast, developer of medical devices made of electrospun nanofabric, announced it is readying to launch the NovaMesh intra-abdominal hernia mesh in the European market in Q1 2010, pending European regulatory approval. NovaMesh is the first intra-abdominal hernia mesh to utilize the special properties of electrospun nanofabric.

The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.

James Oliver picked up an Xbox game controller, looked up to a video screen and used the device's buttons and joystick to fly through a patient's chest cavity for an up-close look at the bottom of the heart. And there was a sight doctors had never seen before: an accurate, 3-D view inside a patient's body accessible with a personal computer.