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 » FDA Lays Out Some Fiscal 2013 Generic User Fee Rates; ANDAs to Cost About $50K
FDA Lays Out Some Fiscal 2013 Generic User Fee Rates; ANDAs to Cost About $50K
Teva Pharmaceuticals has resolved a long-outstanding warning letter for its Irvine, Calif., plant, the company said on its third-quarters earnings call Nov. 1. Upgrades to the building and systems, as well as to manufacturing and quality processes, led to last month’s resolution of the letter, CEO and President Jeremy Levin said. The facility’s focus continues to be on producing the life-saving drugs on the FDA’s drug shortage list. Generic Line