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 Drug User Fee Rates; ANDAs to Cost About $50K
FDA Lays Out Some Fiscal 2013 Generic Drug User Fee Rates; ANDAs to Cost About $50K
ANDA filers that have submitted an application on or after Oct. 1 must pay $51,520 in user fees, according to the FDA’s 2013 generic drug user fee rates announced Wednesday. Prior approval supplement (PAS) filers will owe the FDA half as much as ANDA filers, or $25,760. Fees are due on the date of submission; however, if an ANDA or PAS filer submitted an application before the fees are formally set on Thursday, it has until Nov. 24 to pay the fee. Drug Industry Daily