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...
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...
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...
During the first full week of September, the Food & Drug Administration (FDA) released a draft guidance titled “Statement of Identity and Strength–Content and Format of Labeling for Human Nonprescription Drug Products.”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...
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