Over-The-Counter Monograph Drug User Fee Program (OMUFA) ++

https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa?utm_campaign=42504259-FnB%2C%20Cosmetics%2C%20Med%20Dev%2C%20Drugs%20%7C%20Newsfeed%20%7C%20Global%20%7C%202026&utm_medium=email&_hsenc=p2ANqtz-_qWG_H0jozY4gX1FWGKIDWClmVb6_F0hz5szoMFQnQhUAS18gnrU6e-CmoQWMP4jO8k7du0qqFBOsu22MNR8QZpyjw7w&_hsmi=434886669&utm_content=434887044&utm_source=hs_email FDA has published the FY 2027 Over-the-Counter Monograph Drug User Fee (OMUFA) rates, which take effect October 1, 2026, through September 30, 2027. Facility fees have increased significantly compared to FY 2026, and manufacturers should prepare for the program's new two-installment payment schedule. Companies should review the updated fee structure now to ensure timely payments and maintain compliance ahead of the new fiscal year. Generic Drug User Fee Amendments FDA has released the FY 2027 Generic Drug User Fee Amendments (GDUFA) rates, effective October 1, 2026. The ANDA and Drug Master File (DMF) fees have increased, while facility fees for API, finished dosage form, and contract manufacturing organizations have decreased. Generic drug manufacturers should review the complete fee schedule and budget accordingly before the start of the new fiscal year. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments?utm_campaign=42504259-FnB%2C%20Cosmetics%2C%20Med%20Dev%2C%20Drugs%20%7C%20Newsfeed%20%7C%20Global%20%7C%202026&utm_medium=email&_hsenc=p2ANqtz-_gdmLvVXSMoGzDrEKwZm7EmDy2QWR5VajiQTyofMT9eg-1Akd4GrXv6l3X3HBM3lvYff-W3lpAlAU72D6XCiukCuUacg&_hsmi=434886669&utm_content=434887044&utm_source=hs_email