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...
The Food & Drug Administration’s (FDA) Hazard Analysis and Critical Control Points (HACCP) principles and practices started as a joint project between NASA and Pillsbury in the 1960s. The goal of HACCP was to ensure safe food for NASA’s astronaut program. Since...
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...
During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.” This guidance outlines suggestions for...
The Biden administration has declared monkeypox to be a public health emergency in the United States. This is going to likely result in emergency use authorizations (EUAs) for medical products to diagnose and perhaps even reduce the symptoms related to the spreading...
On March 3, 2022, the U.S. Food & Drug Administration (FDA) issued a guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff,” to help companies prepare for voluntary recalls. Part 7 of Title 21 of the Code of...
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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