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 has issued dozens of draft and revised draft product-specific guidances that detail its recommendations for bioequivalence (BE) studies to support ANDAs. New draft product-specific BE recommendations are available for 32 drug products. Drugs with the active ingredients amoxicillin, budesonide, linagliptin, omeprazole and paclitaxel are just a few of those listed in the FDA’s Sept. 14 Federal Register notice. Generic Line