On February 5, 2024, FDA issued a final guidance regarding reporting by drug establishments for listed drug and biological products manufactured, prepared, propagated, compounded, or processed for commercial distribution. The upshot is that drugs listed with FDA must...
The Association of American Feed Control Officials (AAFCO) recently developed new Model Regulations for Pet Food and Specialty Pet Food. AAFCO model rules are used by most states as part of their charge to regulate the manufacture, sale, and distribution of animal...
FDA recently announced the updated medical device fees for the 2024 fiscal year (October 1, 2023 – September 30, 2024). All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. Please do not wait until the...
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
During the 2020 biennial renewal period, FDA began requiring food facilities to include a unique facility identifier (UFI) on their registration. The required UFI must be a DUNS number obtained through third-party company Dun & Bradstreet. FDA extended this due...
After several decades, the U.S. Food and Drug Administration (FDA) will soon be required to update its regulation of cosmetic products following the amendment to Chapter VI of the federal Food, Drug, and Cosmetic Act (FDCA) as a part of the “Modernization of Cosmetics...
UPDATE:Breaking News: The Medical Device User Fees have just been announced for FY2023. The Annual Establishment Registration Fee is $6,493. Other fees are now listed and can be found...
Over the past several years, the Food and Drug Administration (FDA) has been phasing in requirements for Unique Device Identifiers (UDI) to be displayed on various classes of medical devices. The UDI system identifies medical devices sold in the United States and is...
In October of 2020, the Food and Drug Administration (FDA) introduced the requirement for all food facility registrations to include a UFI (Unique Facility Identifier). Currently, FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs...
Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply...
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