Generic Drug User Fee Amendments (GDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due 1 October 2025.
User Fee Type |
FY 2026 |
|
| ANDA DMF |
$ 358,247 $ 102,584 |
|
Program |
||
| Large Size Medium Size Small Size |
$ 1,918,377 $ 767,351 $ 191,838 |
|
Facility |
||
| Domestic API Foreign API Domestic FDF Foreign FDF Domestic CMO Foreign CMO |
$ 43,549 $ 58,549 $ 238,943 $ 253,943 $ 57,346 $ 72,346 |
|
Medical Device User Fee Amendments (MDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due prior to submitting your medical device establishment registration renewal, between 1 October and 31 December 2025.
Annual Establishment Registration Fee: $11,423
Application Fees:
Application Type |
Standard Fee |
Small Business Fee |
| 510(k) 513(g) PMA, PDP, PMR, BLA De Novo Classification Request Panel-track Supplement 180-Day Supplement Real-Time Supplement BLA Efficacy Supplement 30-Day Notice |
$26,067 $7,820 $579,272 $173,782 $463,418 $86,891 $40,549 $579,272 $9,268 |
$6,517 $3,910 $144,818 $43,446 $115,855 $21,723 $10,137 $144,818 $4,634 |
FY2026 PDUFA program fee invoices were emailed by the agency on 18 August 2025. Do note, the payment for this user fee is due 1 October 2025. Rates were published in the Federal Register (link below).
Fee Category |
Fee Rates for FY 2026 |
|
| Application | ||
| Requiring clinical data Not requiring clinical data |
$4,682,003 $2,341,002 |
|
| Program | $442,213 | |
EAS has learned that the ORAPHARMInternational483responses@fda.hhs.gov mailbox is no longer active for receiving foreign facility 483 responses. The agency has provided the following guidance:
Please use the following mailboxes for foreign pharmaceutical inspections.
- For human drug CGMP inspections, please email the Center For Drug Evaluation Research, Office of Manufacturing Quality (CDER OMQ), at the following email CDER-OC-OMQ-International483Response@fda.hhs.gov
- For human drug, pre-approval inspectional (PAI) coverage, please email CDERPAIprogram@fda.hhs.gov
- For animal drug inspections, please email the Center for Veterinary Medicine (CVM), at the following email address: CVM-483-responses@fda.hhs.gov
- For human drug CGMP and PAI email CDER-OC-OMQ-International483Response@fda.hhs.gov and CDERPAIprogram@fda.hhs.gov
The FDA has issued several warning letters for sunscreen products advertised with “foam, whip or mousse” identified as the dosage forms. The warning letters note that the FDA monograph only allows for the dosage forms of “oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder”. A sunscreen drug product that does not comply with Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use is considered a new drug and would need to be submitted to the agency for approval. If you have concerns about your products labeling or claims, EAS can assist.
As we all return to normal after our summer holidays, keep in mind that the drug establishment and medical device facility registration renewal period will begin shortly. Make your plans now to submit your renewals early and avoid any issues with the hectic end of the year holiday rush. The renewal period opens 1 October 2025.
Highlighted Guidance Documents
Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations
DRAFT: Submit Comments by 09/02/2025
Medical Device User Fee Small Business Qualification and Determination
This final guidance updates the previous version of the guidance, titled “Medical Device User Fee Small Business Qualification and Certification; Guidance for Industry, Food and Drug Administration Staff and Foreign Governments,” issued on August 1, 2018. The guidance includes updates that describe how FDA will determine if a small business is experiencing “financial hardship,” which would make the business eligible for a waiver of their registration fee (“Small Business Registration Fee Waiver”). The guidance details the types of information an entity seeking the waiver may submit for FDA’s consideration in determining whether to grant the Small Business Registration Fee Waiver, including entities that are in jurisdictions without a national taxing authority. The guidance is also being updated to reflect the planned replacement of Forms 3602 and 3602A with a single combined form (Form 3602N).
The FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness. The FDA reviews the PCCP as part of a marketing submission for an AI-enabled device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP. The recommendations in this guidance apply to AI-enabled devices, including the device constituent part of device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways. The recommendations in this guidance build on FDA’s longstanding commitment to develop and apply innovative approaches to the regulation of AI-enabled devices.
All Guidance Documents can be searched on the FDA’s website.
Federal Register
- FR Vol 90, No. 144 Generic Drug User Fee Rates for Fiscal Year 2026
- FR Vol 90, No. 144 Medical Device User Fee Rates for Fiscal Year 2026
- FR Vol 90, No. 144 Prescription Drug User Fee Rates for Fiscal Year 2026
Meetings
Date: September 10, 2025
Time: 1:00PM–5:00PM ET
Date: September 10, 2025
Time: 8:00 a.m. – 9:00 a.m. ET
ICH M13B Webinar: Navigating the Draft ICH M13B Additional Strengths Biowaiver Guideline
Date: September 11, 2025
Time: 12:00 p.m. – 2:00 p.m. ET
Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned
Date: September 23, 2025
Time: 9:30AM–4:00PM ET
Dates: September 23 – 24, 2025
Day1: Tue, Sep 23 8:30 a.m. – 05:30 p.m. ET
Day2: Wed, Sep 24 8:30 a.m. – 04:20 p.m. ET
Date: September 30, 2025
Time: 9:30 a.m. – 10:40 a.m. ET
Location:
White Oak Campus: The Great Room
FDA Headquarters
10903 New Hampshire Avenue
Bldg. 31, Great Room Conference Center
Silver Spring, MD 20993-0002, United States
Advancing Generic Drug Development: Translating Science to Approval 2025
Date: October 7 – 8, 2025
Day1: Tue, Oct 07 9:00 a.m. – 04:00 p.m. ET
Day2: Wed, Oct 08 9:00 a.m. – 03:00 p.m. ET
Date: October 15-16, 2025
Time: 8:30 am – 5:30 pm
Co-hosts: FDA and the Center for Research on Complex Generics (CRCG)
Pediatric Developmental Safety Assessment: New Approach Methods
Date: December 5, 2025
Time: 8:00 a.m. – 4:00 p.m. ET
Location:
FDA, White Oak Campus, The Great Room
Building 31
10903 New Hampshire Avenue
Silver Spring, MD 20903, United States
FDA Websites of Interest
- HHS Allows FDA Emergency Use of Animal Drugs to Combat New World Screwworm, Protect U.S. Food Supply
- FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
- Report on the State of Pharmaceutical Quality
- PFAS in Medical Devices
- FDA’s Actions to Address Unapproved Thyroid Medications
- FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
- FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term use
- Regulatory Accelerator (a collection of resources for innovators of digital health)
Posted in Drug and Device Corner, Drugs, Medical Devices.