Jul 5, 2023 | Issue of the Month, Medical Devices
Biofilms and Healthcare By David W Koenig, PhD., EAS Consulting Group Independent Consultant Healthcare facilities — such as hospitals, nursing homes and outpatient facilities — are opportunistic locations for acquiring secondary infections unrelated to a...
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...
Mar 28, 2023 | Drug and Device Corner, Drugs, Medical Devices
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 Fee: $17,435....
Feb 27, 2023 | Drug and Device Corner, Drugs, Medical Devices
The FDA sent email reminders in February re mandatory CARES annual reporting for drug establishments, which are due now. CARES volume reporting has been an annual requirement since passing of the CARES Act in 2020. If you have not already submitted your 2020 and 2021...
