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 » Supreme Court Faces Choice on Pay-for-Delay Cases
The FTC Thursday asked the Supreme Court to take up and overturn an 11th Circuit Court’s decision that upheld the legality of reverse patent settlements between branded drug makers and generic competitors. The FTC argues the 11th Circuit erred when it ruled against the commission in its challenge to Watson Pharmaceuticals’ and Abbott Laboratories’ agreement to delay a generic version of testosterone replacement AndroGel. Drug Industry Daily