ARTICLE | Politics & Policy

FDA announces new user fee rates

September 15, 2017 8:35 PM UTC

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. ...