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.
Telemetry company ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 closeout letter from the FDA’s Cincinnati District Office. “It appears that you have addressed the violations contained in this [Feb. 21] warning letter,” the agency said, adding further inspections will assess the adequacy and sustainability of those actions. The GMP Letter