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...
Jan 9, 2025 | Drugs, FDA and USDA Regulatory Update
January 2025 Docket Number: FDA-2024-D-5374 Issued by: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine Download the Draft Guidance Document Read the Federal Register Notice This guidance, when...
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...
Dec 24, 2024 | Drugs, FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration issued a final rule establishing requirements for a nonprescription drug product with an additional condition for nonprescription use (ACNU). A nonprescription drug product with an ACNU is a drug product that could be...
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...
