FDA Delays Application For First Human Trial Of Embryonic Stem Cells (Medical News Today)
The company Geron on Wednesday announced that it has received oral notice from FDA that the agency is delaying a decision on the company's application for the first clinical trial using human embryonic stem cells in humans, Bloomberg/New York Times reports.

St. Jude Medical Announces FDA And European CE Mark Approvals Of The IsoFlex Optim Pacing Lead (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of the IsoFlex Optim pacing lead. The small-diameter lead is built on the proven IsoFlex pacing lead platform, and features the company's exclusive Optim insulation material. With the addition of Optim insulation to IsoFlex leads, all St.

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (Medical News Today)
The U.S. Food and Drug Administration (FDA) announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.