The 2025 OMUFA facility user fees have been announced in the Federal Register (see link below).
| Facility User Fee Rates | FY 2025 |
| Monograph Drug Facility (MDF) Fee | $37,556 |
| Contract Manufacturing Organization (CMO) Fee | $25,037 |
The background and legislation on this program can be reviewed on the FDA’s website. The 2025 facility user fees are due no later than Monday 2 June 2025. If you have questions or need assistance processing your cover letter, please reach out to Victoria Pankovich at EAS.
EAS is once again seeing an increase in Warning Letters issued by CDER for sightings related to CGMP/Finished Pharmaceuticals/Adulterated drug products. EAS can provide a cGMP audit of your facility to assist in preparedness for an FDA inspection. Please contact EAS for further information on our auditing services if you would like to have your facility assessed.
As we approach the one year mark for the majority of firms complying with MoCRA cosmetic facility registration and cosmetic product listing requirements, the FDA has published summary data on the submissions they have received. The numbers are quite impressive with 9,528 unique, active facility registrations and 589,762 unique, active product listings. The agency’s Registration & Listing of Cosmetic Product Facilities and Products webpage has been updated to include this information. Requirements are also clearly articulated on the website along with an industry decision tool to assist companies in evaluating whether their facility / products must comply at this time. The website also reiterates the submission tools, compliance dates, and guidance documents available to support industry with these requirements. EAS is here to assist if you have any questions on this new process.
Guidance Documents can be searched on the FDA’s website.
Federal Register
Federal Register Vol 90, No. 54 Over-the-Counter Monograph Drug User Fee Program—Facility Fee Rates for Fiscal Year 2025
Meetings
Generic Drugs Forum (GDF) 2025
Date: April 9 – 10, 2025
Day1: Wed, Apr 09 8:30 a.m. – 05:00 p.m. ET
Day2: Thu, Apr 10 8:30 a.m. – 05:00 p.m. ET
Location:
Bethesda North Marriott
Hotel & Conference Center
5701 Marinelli Road
Rockville, MD 20852, United States
Virtual attendance is an option.
FDA Websites of Interest
- Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination
- Influenza Vaccine Composition for the 2025-2026 U.S. Influenza Season
- FDA issues class-wide labeling changes for testosterone products
- Accelerating Rare disease Cures (ARC) Program
- Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
- Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
Posted in Drug and Device Corner, Drugs, Medical Devices.