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 » Industry Unprepared for Malware Threat, IT Security Expert Says
Industry Unprepared for Malware Threat, IT Security Expert Says
The device industry remains largely unprepared for the risk posed to technology by malware and computer viruses, one computer security expert says. While no adverse events have been directly attributed to computer viruses or malware, Kevin Fu, an associate professor in the computer science department at the University of Massachusetts-Amherst, said there is nothing to prevent such occurrences. The GMP Letter