For those not already aware, the US government shutdown has ended. The User Fee system is now open and accepting FY2026 payments.
The first step for renewal of your Medical Device facility is to pay the FDA FY2026 Medical Device Annual Establishment Registration User Fee of $11,423. This process will generate the necessary PIN / PCN numbers which will be required for the registration renewal. If you have questions on how to process the payment, do not hesitate to reach out to EAS.
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be updated and submitted to reactivate the listing. If you need assistance with the process, or would like EAS to handle this for you, please contact Victoria Pankovich.
The FDA Pilots Faster Clarifications to Meeting Minutes program is designed to offer prompt feedback to sponsors’ clarification questions following a formal meeting with the agency. Questions can be submitted via email with an FDA goal of responding within 3 business days via email. This pilot program launched in October 2025 with the Office of New Drugs and is anticipated to expand to other FDA divisions. Please see the website for specific details on the program.
Highlighted Guidance Documents
This guidance is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the reference listed drug (RLD) with respect to the pH adjuster(s). This guidance describes how FDA intends to evaluate a request for a waiver of Agency requirements for a Q1 or Q2 difference in pH adjuster, including recommendations on the type of information to provide in support of such a waiver request. This guidance finalizes the draft guidance of the same title issued on April 14, 2022.
This guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides a comprehensive and systematic approach to pediatric extrapolation during drug development. The guidance is intended to provide approaches that can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. The guidance replaces the draft guidance “E11A Pediatric Exploration” issued on August 29, 2022.
Submit Comments by 01/20/2026
All Guidance Documents can be searched on the FDA’s website.
Meetings
Quality and Regulatory Predictability: Shaping USP Standards
Date: December 11, 2025
Time: 9:00 a.m. – 10:30 a.m. ET
Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine
Date: December 16, 2025
Time: 9:00 a.m. – 4:30 p.m. ET
Location: (virtual and in person)
Duke in DC Office
Conference Center
1201 Pennsylvania Ave. NW, Suite 500
Washington, DC 20004
United States
FDA Websites of Interest
- Product-Specific Guidances for Generic Drug Development (new additions)
- Using Four-Part Harmony in OGD-Related Assessment Communications (MAPP 5521.3 Rev 1)
- FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
- FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
- Report on the Certification of Color Additives: 4th Quarter, Fiscal Year 2025, July 1-September 30
Posted in Drug and Device Corner, Drugs, Medical Devices.