BioCentury
ARTICLE | Politics & Policy

FDA releases FY16 PDUFA fees

August 1, 2015 12:01 AM UTC

FDA posted PDUFA fees for drug, biosimilar, and medical device marketing applications for FY16.

Fees for drug applications containing clinical data will be $2.4 million, or $1.2 million without clinical data; last year's fees were $2.3 million per clinical application and $1.2 million per non-clinical application. FDA will charge a product fee of $114,450 for each approved drug in an application, and an establishment fee of $585,200 for each facility manufacturing the product. ...