FDA

FDA Nixes Wider Use of Iron Therapy
The FDA has turned down wider use of the iron therapy ferumoxytol (Feraheme), currently limited to use in patients with chronic kidney disease, the drug's manufacturer announced Wednesday. Drugmaker AMAG Pharmaceuticals wanted to expand the indication to include all adult iron-deficiency anemia patients who can't tolerate oral iron treatment, but in its complete response letter, the FDA said the company hadn't provided sufficient data for broadening the label. MedPage Today

FDA's Approval Processes Scrutinized in JAMA
Three JAMA studies of the FDA's approval processes may stir conversation. Examined are the agency's criteria for drug approval, the strength of evidence supporting its decisions, and the vagaries of cardiac device approval. Journal Watch

FDA Initiates New Online Reporting Method for Dietary Supplement Adverse Events to Facilitate Reporting
The U.S. Food and Drug Administration (FDA) is now accepting online submission of voluntary and mandatory dietary supplement adverse event reports.

The FDA has implemented a secure capability in the interest of efficiency and as a convenience to dietary supplement manufacturers, packers and distributors, as well as the public at large. Both mandatory and voluntary dietary supplement adverse event reports (currently the 3500A and 3500 forms, respectively) may now be submitted online.  NCCAM