The FDA has announced fiscal year 2018 rates under the Generic Drug User Fee Amendments (GDUFA) for contract manufacturing organization facilities.   The CMO finished dosage form (FDF) facility fee for FY18 is $70,362 for a U.S. site, and $85,362 for a non-U.S. site. According to PBOA president Gil Roth, this fee is a significant drop from FY17’s FDF fee of $258,646. The non-CMO FDF fee is $211,087 for a U.S. site and $226,087 for a non-U.S. site. According to Mr. Roth, if the PBOA was n...