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.
The FDA’s Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls. The move toward a global system, currently in its early stages, would help address fast-growing gaps in global oversight of international product recalls, Mark Roh, regional food and drug director for the FDA’s Pacific Region, said. Drug Industry Daily