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.
Cispharma has received a Form 483 with several manufacturing observations, including a lack of evidence that a distributed portion of a lot was acceptable. The reserve samples had “scarred and eroded caplets,” the April 23 form notes. FDA investigators also found the company’s manufacturing and packaging processes for drug products had not been validated. Drug GMP Report