May 31, 2023 | Drugs, FDA and USDA Regulatory Update
A recent FDA warning letter concerning identity testing and contaminated glycerin highlights the significance of a recurring potential public health hazard. After several lethal poisonings worldwide, it is apparent that high-risk drug components contaminated with...
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...
Feb 1, 2023 | Drugs, Issue of the Month
Process and Manufacturing Optimization to Minimize Inflation Impact on the Pharmaceutical Industry By Ibrahim Khattab, EAS Independent Consultant Rising inflation rates, the Russian invasion of Ukraine and the associated rise in energy prices, and the numerous...
