A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
Since 1992, the U.S. has consistently spent about six percent of its national healthcare dollar on medical devices, according to a new report. A med tech lobbying group issued the report as part of an effort to seek repeal of a device tax in recent health care reform legislation. EE Times