The FDA and the Department of Health and Human Services published the Generic Drug User Fee Rates for Fiscal Year 2020 specifying fees for ANDA and DMF submissions, annual active ANDA holdings, and API and finished dosage form (FDF) facilities next fiscal year, beginning October 1, 2019. Thanks to efforts during GDUFA II negotiations by PBOA, a non-profit trade association that represents the interests of pharma and biopharma CMOs and CDMOs, CMO facilities (which are defined as FDF sites that a...