Mar 25, 2025 | Drug and Device Corner, Drugs, Medical Devices
The 2025 OMUFA facility user fees have been announced in the Federal Register (see link below). Facility User Fee Rates FY 2025 Monograph Drug Facility (MDF) Fee $37,556 Contract Manufacturing Organization (CMO) Fee $25,037 The background and legislation on this...
Feb 26, 2025 | Drug and Device Corner, Drugs, Medical Devices
Reminder that CARES volume reports for 2024 are due no later than 31 March 2025. If you need assistance with the process, EAS is here to help. The FDA has updated the OTC MONOGRAPHS @ FDA website’s OTC Monograph Resources section. This includes a digital Catalogue of...
Jan 29, 2025 | Drug and Device Corner, Drugs, Medical Devices
Effective January 20, 2025, The President issued a Regulatory Freeze Executive Order, which will have a direct impact on regulated industries. The regulatory freeze order, consistent with the actions of previous incoming administrations, effectively halts any...
Dec 31, 2024 | Drug and Device Corner, Drugs, Medical Devices
The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU). This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user...
Nov 25, 2024 | Drug and Device Corner, Drugs, Medical Devices
This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024. If you need help with your submissions, please...
Oct 28, 2024 | Drug and Device Corner, Drugs, Medical Devices
Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact...
