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...
Jan 30, 2023 | Drug and Device Corner, Drugs, Medical Devices
On 29 December 2022, the U.S. President signed H.R 2617 – the Consolidated Appropriations Act, 2023 into law which includes the Food and Drug Omnibus Reform Act. Of particular interest in this legislation for EAS drug and device clients, are the following: The...
Jan 4, 2023 | Drugs, FDA and USDA Regulatory Update
What You Need to Know The U.S. Food and Drug Administration has issued a final guidance on Homeopathic Drug Products describing the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. The agency...