Application Fees Going Up for Rx Drugs, Down for Biosimilars in 2018
Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing.
Under the legislation enacted in August that reauthorized the fee program for the next five years, the target for the annual total of prescription drug fee collections grew by nearly $160 million to $878.59 million for fiscal 2018.
For a prescription drug application requiring clinical data, the fee increases to $2.42 million, from $2.04 million in fiscal 2017. For an application without clinical data, the fee increases to $1.21 million, from $1.02 million.