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.
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis.
The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity.
Home » China Department of Health Issues Stent System Device Alert
China Department of Health Issues Stent System Device Alert
Cordis stent defect leads to a field safety notice for its S.M.A.R.T. Control Nitinol stent system due to a potential sterility breach in the pouches of all unexpired lots. The Chinese Department of Health said the potential defect was detected during in-house testing on non-production product as part of a development project.