Drug and Device Corner 2025 December

Reminder that if the 31 December registration renewal deadline is missed, drug and medical device facility registrations will drop off the public databases. Registrations can be reactivated with a successful renewal submission. Any NDC drug listings that miss the blanket no change certification period, which ends on 31 December, will need to submit a listing update in January to avoid inactivation of the NDC by the agency. Each individual SPL file will need to be submitted.

EAS has received numerous reminders from Cosmetics Direct regarding the upcoming initial biennial cosmetic registration renewals. The first cosmetic facility registrations were submitted in December 2024, therefore the first batch of required renewals are upon us. 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). Regarding cosmetic product listing updates, these files must be annually updated 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 FDA announced on 11 December 2025 that it is proposing to add bemotrizinol to the sunscreen monograph as a permitted active ingredient. This move is in response to an OMOR (OTC monograph order request). The agency is requesting comments on the Proposed Order OTC000039. Comments are due no later than 26 January 2026. Federal Register Vol 90, No. 237 has full details of the proposed order and the commenting process.

The FDA is seeking public comment on their planned regulatory action which would place suitable medical device accessories in class I. The medical device accessories that would qualify are those that already have marketing authorization (an existing accessory). The other qualifying requirement is sufficient evidence provided through general controls to establish safety and effectiveness. Full factors to consider are available on the CDRH Seeks Public Comment: Identifying Accessories Suitable for Distinct Classification as Class I Devices website. The public comment deadline is 3 February 2026.

The FDA announced on 15 December 2025 that it is shifting one aspect of their policy regarding real-world evidence (RWE) used in drug and device applications. For certain types of medical devices, the agency will not require identifiable individual patient data to be submitted in marketing authorization applications. The new approach is expected to open access to large databases that do not include identifiable patient data but do provide insights and macro-level data that may be used to demonstrate results of real-world treatments. Please review the website FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews for full details.

The FDA has thus far granted 18 products a “National Priority Voucher” in their efforts to improve the availability and affordability of drug products to U.S. consumers. This program was covered in an earlier DD Corner issue.

Highlighted Guidance Documents

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers

This guidance addresses questions that manufacturers, packers, distributors, and their representatives may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act. The guidance discusses considerations for presenting data and information about reference products or biosimilar products in promotional communications to help ensure that they are accurate, truthful, and non-misleading.

Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies | FDA

The guidance provides recommendations for sponsors and sponsor-investigators to comply with the requirements of investigational new drug application safety reporting and safety reporting for bioavailability and bioequivalence studies. This guidance provides interpretations of terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors.

Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA

The guidance is intended to help clinical investigators comply with the safety reporting requirements for investigational new drug application studies and investigational device exemption studies.

DRAFT Q3E Guideline for Extractables and Leachables

Submit Comments by 01/30/2026

DRAFT Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs

Submit Comments by 01/30/2026

DRAFT Medical Gases — Current Good Manufacturing Practice

Submit Comments by 01/30/2026

DRAFT Monoclonal Antibodies: Streamlined Nonclinical Safety Studies

Submit Comments by 02/02/2026

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