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Drug and Device Corner 2026 September

Sep 29, 2026 | Drug and Device Corner, Drugs, Medical Devices

Drug and Device

NDC format change is coming. Although there is a seven-year delayed implementation, time does fly. Six months have already passed since announcement of this regulation on 5 March 2026. If you have not yet begun to discuss internally how these changes will be managed, now would be a good time to start. The ripple effect outside of your company should be taken into account. If you feel you could benefit from discussing with a consultant, reach out to EAS.

REMINDER: The drug and medical device establishment registration renewal and listing certification period begins on Thursday 1 October 2025. Facilities that manufacture OTC monograph drugs are reminded that the data pulled for assessing FY2028 OMUFA user fees are based on active registrations from 1 October 2026 through 30 September 2027. Private Label Distributors that manage their own NDC listing submissions should be aware of the listing certification process. EAS is here to assist our clients with facility registration renewals and product listing updates or certifications, do not hesitate to reach out if you need assistance.

In response to numerous requests, the FDA has issued a statement that Clarifies It Does Not Provide Certificates or Other Documents to Verify Compliance for Cosmetic Product Facility Registration. There is no public database to confirm a cosmetic facility registration or product listing. The agency has also included in their statement that these requirements are not intended to be used as marketing tools. Registration of a cosmetic facility or listing of a cosmetic product does not imply approval by the agency for the facility or cosmetic product. This is simply an administrative process to provide information to the FDA. The biennial renewal of cosmetic registrations has begun. The renewal date is based on your initial registration submission date. If you have any questions, contact EAS.

Highlighted Guidance Documents

DRAFT CVM GFI 256B – Compounding Animal Drugs from Bulk Drug Substances: Compounding under CGMP in Federally-Registered Facilities

Submit Comments by 11/27/2026

DRAFT Potency Assessment of Active Immunotherapy Products

Submit Comments by 11/18/2026

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

Federal Register

Meetings

Navigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations

Date: October 14, 2026
Time: 12:00 p.m. – 1:00 p.m. ET

Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) – 10/26/2026 | FDA

Date: October 26, 2026
Time: 9:00 a.m. – 12:00 p.m. ET

FDA Websites of Interest

Posted in Drug and Device Corner, Drugs, Medical Devices.