Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. 2025 reports are due no later than 31 March 2026. Reminder that the agency began their policy enforcement late in 2025 contacting facilities that had not reported all NDC volumes. If you have questions or need support with this process, please reach out to EAS.
The agency began their email reminders to registered cosmetic facilities RE submittal of their biennial renewals. Keep in mind cosmetic facility registration renewal dates are based on initial registration submission. Cosmetic facility registration renewals can be submitted earlier than due, however, this will result in a new renewal date. There is a specific field to identify your registration submission as a biennial renewal. A website has been launched to share information about the updates made to the Cosmetics Direct platform and available materials to guide the process. Reach out to EAS if you need assistance.
The amended medical device current good manufacturing practice (cGMP) requirements [21 CFR 820] went into effect 2 February 2026. This update aligns the FDA cGMPs with ISO 13485. The agency will now be conducting medical device inspections per Compliance Program Manual 7382.850. The Quality Management System Regulation (QMSR) website has further information.
The FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products which offers data on adverse events that have been reported on cosmetics, has been launched. The agency plans to keep this database updated in real-time, as much as possible. Searches can be done for specific products or for the specific reaction type. Reports can also be pulled based on certain criteria.
The agency has launched their PreCheck Pilot Program and is now accepting applications. You may recall from last month’s DD Corner, the goal of this program is to strengthen the domestic pharmaceutical supply chain. For further details, please check the website or review the FDA’s PreCheck Implementation Roadmap.
In light of the FDA’s recent focus on compounded drugs, we are sharing the agency’s Compounding and the FDA: Questions and Answers website for review by any interested parties.
Highlighted Guidance Documents
DRAFT E22 General Considerations for Patient Preference Studies
Submit comments by 7 April 2026
DRAFT Certification Process for Designated Medical Gases
Submit Comments by 13 April 2026
All Guidance Documents can be searched on the FDA’s website.
Meetings
Town Hall – Clinical Decision Support Software, Final Guidance
Date: March 11, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers
Date: April 15, 2026
Time: 1:00 p.m. – 2:30 p.m. ET
Generic Drugs Forum (GDF) 2026 (Virtual and In Person)
Dates: April 22 – 23, 2026
Day1: Wed, Apr 22 9:00 a.m. – 05:00 p.m. ET
Day2: Thu, Apr 23 9:00 a.m. – 05:00 p.m. ET
Joint US-FDA, MHRA-UK, Health Canada Symposium – Registration
June 2-4, 2026 VIRTUAL
Day 1: Tuesday, June 2 | 8:30 AM – 5:15 PM ET
Day 2: Wednesday, June 3 | 8:30 AM – 5:00 PM ET
Day 3: Thursday, June 4 | 8:30 AM – 4:50 PM ET
FDA Websites of Interest
Posted in Drug and Device Corner, Drugs, Medical Devices.