Drug and Device Corner 2026 March

2025 CARES reporting deadline is next Tuesday 31 March 2026!

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.

With the passage of OMUFA II, a few changes have been implemented to the facility user fee structure and payment schedule. For fiscal year 2026 (1 Oct 2025 – 30 Sept 2026), fees are assessed on facilities that were registered between 1 January – 31 December 2025. Fiscal year 2027 (1 Oct 2026 – 30 Sept 2027) user fees will be based on facilities registered between 1 January – 30 September 2026. Beginning fiscal year 2028 (1 Oct 2027 – 30 Sept 2028) and all years following, user fees will be assessed on facilities registered during the period ending 30 September of the previous fiscal year.

The fiscal year 2027 facility user fees will be collected in two installments, each 50 percent of the total due. The first installment will be due 1 October 2026. The second installment will be due on 1 February 2027. For FDA fiscal years 2028 onward, OMUFA user fees will be due on 1 October of the fiscal year, or the first business day following.

The FDA is holding a webinar on OMUFA user fees and registrations, please see the Meetings section of DD Corner for details.

The National Drug Code Format is heading for changes. The agency announced in the Federal Register Vol 91, No. 43 the new format and the implementation date. Included in the FR notice are the comments made by stakeholders and the FDA’s responses to each. Beginning 7 March 2033 all NDCs will transition to a 12-digit format. The 12 digits will consist of a 6-digit labeler code – a 4-digit product code – a 2-digit package code. (xxxxxx-xxxx-xx) Existing NDCs will be converted by adding leading 0s to any section requiring such to conform to the new format. The FDA is allowing a three-year transition period between 7 March 2033 – 6 March 2036. The FDA has allowed for a seven-year preparation period for this transition. This will be a significant undertaking, so companies should begin to formulate their transition strategies as soon as possible. Further details can be found on the National Drug Code Format website and in the FR notice.

Highlighted Guidance Documents

DRAFT Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection
Submit Comments by 05/08/2026

DRAFT New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)
Comments may be submitted at any time to Docket Number FDA-2011-D-0611

DRAFT New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers
Comments may be submitted at any time to Docket Number FDA-2024-D-4388

DRAFT General Considerations for the Use of New Approach Methodologies in Drug Development
Comments may be submitted at any time to Docket Number FDA-2025-D-6131

Medical Devices with Indications Associated with Weight Loss – Premarket Considerations

This guidance document provides the FDA’s recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions. The guidance also includes discussion on how FDA considers the benefit-risk analysis to support such indications.

Questions and Answers on Biosimilar Development and the BPCI Act

This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer format is intended to inform prospective applicants and facilitate the development of proposed biosimilar and interchangeable biosimilar products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers

This guidance provides information for industry, researchers, physicians, institutional review boards, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application, which went into effect on October 13, 2009.

E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” by clarifying the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs). This final guidance clarifies the use of new postapproval safety sources and update terminology and standards for postapproval adverse event reporting. The guidance replaces the draft guidance issued on March 14, 2024, and the final guidance issued September 15, 2003.

M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

This guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance updates the 2003 guidance titled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” by clarifying the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs). This final guidance clarifies the use of new postapproval safety sources and update terminology and standards for postapproval adverse event reporting. The guidance replaces the draft guidance issued on March 14, 2024, and the final guidance issued September 15, 2003.

QTc Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry

This guidance is intended to assist applicants with incorporating heart rate-corrected QT interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products.

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs

This guidance is intended to assist applicants who submit abbreviated new drug applications for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as “topical products”). This guidance provides recommendations for physicochemical and structural (collectively, “Q3”) characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)). This guidance finalizes the draft guidance of the same title issued on October 21, 2022.

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