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.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
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