St. Jude Medical Announces FDA Clearance and European Approval of New Electrophysiology Products (RedNova)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of the Reflexion Spiral Variable Radius Mapping Catheter and a faster, smaller EnSite System workstation computer. St.

FDA Makes 'Suboptimum' Use Of Advisory Committees, Group Says (Medical News Today)
FDA is "making suboptimum use of its drug advisory committee system," according to a letter from the Health Research Group at Public Citizen published in the current issue of the Lancet, USA Today reports. [click link for full article]

Drugmakers agree to 29 percent hike in regulator fees (Asbury Park Press)
Drugmakers, who represent New Jersey's biggest industry, agreed to a 29 percent increase in payments to U.S. regulators to ensure speedy approvals of new medicines and step up safety monitoring, according to the Food and Drug Administration. Payments to the FDA for new-medicine applications would jump by at least $87.3 million to $392.8 million in the fiscal year starting in October, according to ...