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Drug and Device Corner 2026 January

Jan 26, 2026 | Drug and Device Corner

Drug and Device

Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. 2025 reports are due no later than 31 March 2026. The agency began their policy enforcement late in 2025 contacting facilities that had not reported all NDC volumes. Any 2024 CARES reports that were not completed will result in the facility being included in the noncompliant entities list on FDA.gov. It is imperative that NDCs that are no longer marketed be properly delisted to avoid issues with CARES reporting. If you have questions or need support with this process, please reach out to EAS.

EAS presented a free webinar in December covering the changes to 21 CFR 820 QMSR announced in the Federal Register Vol 89, No. 23 dated 2 February 2024. The effective date of these updates is 2 February 2026. The major change to the 820 regulations is the incorporation by reference of the ISO 13485 standards, aligning FDA’s quality system requirements with international standards. If you are not certain you’ve made the necessary updates to your processes, EAS can assist. Contact Victoria Pankovich or Lisa El-Shall for further information.

Is your FDA cosmetic registration up to date? Contrary to most FDA facility registration renewals, cosmetic registration renewal timing is based on initial submission, not a specific period during the year. Please ensure you are aware of your facility’s renewal date (2 years post initial submission). Your registration will expire if not renewed by the expiration date. Regarding cosmetic product listing updates, these files are required to be updated annually with any changes by the end of December. It is voluntary to submit a notification if there are NO changes to a cosmetic product.

The agency has announced their PreCheck Implementation Roadmap on 21 January 2026. The PreCheck program is designed to strengthen the domestic US drug supply chain with anticipated improvements to the manufacturing facility assessment process. Applications for the pilot program will be accepted beginning 1 February 2026. Please see the website for further details.

Highlighted Guidance Documents

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

This guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the FD&C Act (“Final Order”). This guidance finalizes the draft guidance of the same title issued on June 23, 2023. 

DRAFT Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry
Submit comments to FDA-2025-D-2246 by 17 February 2026

DRAFT Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
Submit comments by 13 March 2026

DRAFT FDA Records Access Authority for Cosmetic Products
Submit comments to FDA-2025-D-2243 by 23 March 2026

DRAFT M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
Submit comments by 23 March 2026

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

FDA Websites of Interest

Posted in Drug and Device Corner.