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.
British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials. Nelson had not identified a corrective and preventive action plan to reduce future occurrence, according to the warning letter, posted recently online. It also failed to determine if a potentially affected product was released for distribution. Drug GMP Report