Drug and Device Corner May 2025

Reminder that OMUFA FY2025 facility user fees are due Monday 2 June 2025. MDF fee is $37,556; CMO fee is $25,037. Please see the FDA website for full details. Do note below the agency will be providing an OMUFA user fee and registration webinar Tuesday 20 May 2025.

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities in their effort to ensure products regulated by the agency are compliant with requirements and safe for U.S. consumers. Do note, the FDA may take regulatory action if an inspection is delayed, denied, limited or refused by a drug or medical device manufacturer. Your facility should review the GMP requirements and assess whether any gaps exist. EAS does provide auditing services, please reach out to Victoria Pankovich if you would like to discuss.

We are continuing to see Warning Letters issued for GMP violations, including one that was issued in response to a records request. With the agency now committed to unannounced foreign facility inspections, it is important to be very aware of GMP requirements and assess your facility for compliance.

The FDA announced on 8 May 2025 they had successfully completed an AI pilot for support of scientific reviews at the agency. The anticipated timeline to scale AI use at all FDA centers is by 30 June 2025, with immediate integration efforts underway. The agency’s goal with the use of AI tools is to assist reviewers with repetitive tasks, freeing reviewers to focus their time on the scientific review. The agency intends to continue to expand the processes and functionality of the tool as they assess the evolving needs of each center. More information can be found on the agency’s website FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

Are your NDC listings up to date? June is the mid-year period to review your listings and ensure any updates needed have been submitted to the agency. Submitting updates now will avoid an end of the year scramble during the certification period.

The agency has emailed the Dear Colleague Letter to all relevant parties for the FY2026 PDUFA program fees. Responses should be submitted to CDERCollections@fda.hhs.gov no later than Monday 2 June 2025.

Guidance Documents can be searched on the FDA’s website.

Federal Register

FR Vol 90, No. 77 Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program

Meetings

SBIA OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration
Date: Tuesday 20 May 2025
Time: 1:00 – 2:00 pm EDT

Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop
Date: June 3 – 4, 2025
Day1: Tue, Jun 03 8:00 a.m. – 05:30 p.m. ET
Day2: Wed, Jun 04 9:00 a.m. – 04:30 p.m. ET

FDA Websites of Interest

• Unleashing Prosperity Through Deregulation – The White House
• FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market