Benjamin England has a unique and extensive background at the intersection of FDA regulations and customs law. With over 20 years of experience, he has worked across various sectors, providing both legal counsel and consulting services to businesses engaged in...
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...
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...
On February 9, 2024, FDA issued “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s...
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...
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...
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