FDA NEWS

Roche receives FDA complete response letter for arthritis drug - Pharmaceutical Business Review
According to the company, the FDA has not requested any new clinical studies surrounding the efficacy or safety of Actemra as a prerequisite for approval. The FDA has requested additional documentation related to the manufacturing of Actemra and
Source: www.pharmaceutical-business-review.com

GE Healthcare says FDA approves imaging agent - Forbes
General Electric Co. said Friday that regulators have approved its imaging agent AdreView to aid in the detection of rare neuroendocrine tumors. GE Healthcare said the injectable agent will help doctors detect tumors including neuroblastoma, a cancer
Source: www.forbes.com

FDA Approves GE Healthcare's AdreView (Iobenguane I 123 Injection - Forbes
GE Healthcare, a unit of General Electric Company (NYSE:GE), today announced that the Food and Drug Administration (FDA) has approved AdreView(TM) (Iobenguane I 123 Injection), a molecular imaging agent for the detection of rare neuroendocrine tumors
Source: www.forbes.com

UPDATE 1-Glaxo says US still reviewing clot disorder drug - Reuters
WASHINGTON, Sept 19 (Reuters) - U.S. health officials still are reviewing GlaxoSmithKline Plc's (GSK.L: Quote , Profile , Research , Stock Buzz ) proposed clotting disorder drug Promacta, the company said on Friday. The London-based drugmaker said it
Source: www.reuters.com

FDA issues rules for genetically modified animals - HealthCentral.com
WASHINGTON (Reuters) - Animals genetically engineered to produce drugs and healthier foods will be subjected to review to help protect consumers from any unknown risks, the U.S. Food and Drug Administration said on Thursday. The FDA published
Source: www.healthcentral.com

FDA warns consumers not to buy milk products from China on the - Newsday
WASHINGTON (AP) _ Although no trace of infant formula from China has turned up in this country, U.S. authorities said Friday they are taking added precautions to keep out tainted milk products. The Food and Drug Administration has widened its
Source: www.newsday.com