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.
Two House Democrats asked the Government Accountability Office (GAO) to investigate the compounding pharmacy industry to look for gaps in federal and state oversight. Reps. John Tierney (Mass.) and Elijah Cummings (Md.) said they are concerned that other compounding pharmacies may have escaped regulatory scrutiny simply because they aren’t known to regulators. Drug Industry Daily