Sep 25, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline...
Aug 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have. If you wish for us to handle the annual requirements, please email Victoria Pankovich to get...
Aug 3, 2023 | Drug and Device Corner, Drugs, Medical Devices
Thinking about an FDA gap assessment this year? Contact EAS now to schedule your 2023 audit. Schedules toward the end of the year tend to book up suddenly, now is the time to lock in your audit, whether it be onsite or virtual. We would be happy to prepare an audit...
Jun 27, 2023 | Drug and Device Corner, Drugs, Medical Devices
The FDA has published a new Guidance Document Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 which explains in great detail the GDUFA program user fee obligations. GDUFA III made slight changes to the user fee structure. (API facility fees...
May 30, 2023 | Drug and Device Corner, Drugs, Medical Devices
As we approach June, keep in mind that drug establishment registrations and NDC listings that have had any changes to their information must update their files with the FDA within 30 days. Failing that, the agency expects updates to be submitted the JUNE or December...
Apr 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that the FDA has announced the 2023 OMUFA user fee rates, please see the Over-The-Counter Monograph Drug User Fee Program (OMUFA) website for full details. Monograph Drug Facility (MDF) Facility fee: $26,153; Contract manufacturing Organization (CMO) Facility...
