FDA announces new user fee rates

FDA released its FY2018 user fee rates for pharmaceuticals and biosimilars Thursday in accordance with PDUFA VI and BsUFA II. The agency raised its application fees by 18.8% for drugs and biologics but lowered those same fees by 14.3% for biosimilars.

For drugs and biologics, the fee for applications requiring clinical data is $2.4 million. Applications not requiring clinical data carry a fee of $1.2 million. In FY2017 those figures were $2 million and $1 million, respectively. ...