The 2026 OMUFA facility registration user fees were published in the 18 March 2026 Federal Register Vol 91, No. 51. There is a lengthy explanation describing how the agency arrived at the user fee amounts. The user fee due on 1 June 2026 has been adjusted down as the result of a carryover fund which had an excess. For FY 2026 the Monograph Drug Facility (MDF) fee is $19,188; the Contract Manufacturing Organization (CMO) fee is $12,792.
Of note regarding the annual OMUFA facility user fee is the agency’s due date change. Beginning with FY2027, OMUFA annual user fees will be due in October to align with the other user fee program due dates. To assist in the transition, the FY2027 user fee will be split into two payments. The first payment will be due in Oct 2026 with the second payment being due Feb 2027. The FY2027 facility fee amount has yet to be announced, EAS will keep you informed when it is.
Highlighted Guidance Documents
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle | FDA
FDA is issuing this guidance to provide recommendations on when and what methods to use to collect and submit patient preference information for a device to FDA. This guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit PPI to aid in FDA-decision making across the total product life cycle. This guidance provides clarity on when and in what contexts different methods are best applied. This guidance supersedes FDA’s guidance “Patient Preference Information – Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.”
DRAFT Establishing Impurity Specifications for Antibiotics
Submit Comments by 06/22/2026
All Guidance Documents can be searched on the FDA’s website.
Federal Register
- Federal Register: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties; Availability
- Federal Register: Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
- Federal Register: Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
Meetings
OTC Monograph Drug User Fee Amendments (OMUFA): Understanding FY 2026 User Fees and Registration
Date: May 5, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
Date: May 5 – 6, 2026
Day1: Tue, May 05 8:30 a.m. – 05:30 p.m. ET
Day2: Wed, May 06 8:30 a.m. – 04:30 p.m. ET
Location: Virtual online
In person: The Universities at Shady Grove
Building II
9630 Gudelsky Drive
Rockville, MD 20850
Date: May 5-6, 2026
Time: 8:30 am – 5:30 pm
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)
In person (at The Universities at Shady Grove; Rockville, MD) and virtual workshop
Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma
Date: May 12, 2026
Time: 9:00 a.m. – 2:00 p.m. ET
Date: May 19 – 20, 2026
Day1: Tue, May 19 9:00 a.m. – 04:50 p.m. ET
Day2: Wed, May 20 9:00 a.m. – 03:50 p.m. ET
Location: Attend In Person or Online
FDA/MHRA/Health Canada Symposium: Regulatory perspectives in good clinical practice, bioequivalence and good pharmacovigilance practice (Virtual only)
Date: June 2 – 4, 2026
Time: 8:30 a.m. – 5:15 p.m. ET
Fiscal Year 2026 Generic Drug Science and Research Initiatives Public Workshop
Date: June 8 – 9, 2026
Day1: Mon, Jun 08 8:30 a.m. – 04:30 p.m. ET
Day2: Tue, Jun 09 8:30 a.m. – 04:30 p.m. ET
Date: June 23, 2026
Time: 1:00 p.m. – 2:30 p.m. ET
Location: Virtual: via webcast
In Person: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503
Silver Spring, MD 20993
FDA Websites of Interest
Posted in Drug and Device Corner, Drugs, Medical Devices.