FDA Regulation of Tobacco Products: Then The road to tobacco regulation has been a long one for FDA. Although the public health consequences of tobacco usage had been observed for several decades, FDA was not very involved in...
Starting on August 2, USDA required all shipments of siluriformes (colloquially catfish)[1] fish and fish products’ to be presented to USDA’s FSIS for re-inspection. While FSIS will perform 100% “re-inspection” for all imported shipments, the agency does not intend to...
The animal food industry experienced a sudden increase in the regulatory obligations in recent years. Through the Food Safety Modernization Act (FSMA) and its implemented regulations, food facilities must now operate under legally established current Good...
Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated Our take... Yeah...not so fast. I expect the Trump-team follow up to be, "we meant 75-80% of the really bad regulations will disappear -- and most likely only in...
FDA essentially banned all powdered medical gloves in the United States starting on Wednesday, January 18, 2017. On that date, not only are the gloves no longer allowed to be manufactured or distributed, but also healthcare providers must dispose of their stocks too....
Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly. Medical...
No one with any experience or regulatory memory at the Food and Drug Administration (FDA) or the United States Department of Agriculture (USDA) wanted the regulation of catfish (and its many cousins) transferred from FDA to USDA. USDA's regulatory requirements are...
When it comes to leak testing for latex products (condoms, medical gloves), FDA is not infallible, and can be challenged. When testing for leak holes in shipments of imported condoms and medical gloves, the Agency adopts a composite sampling method, which increases...
September 22, 2016: Korean Air’s Board (Hanjin’s sister company in the same conglomerate group) has authorized a $60 million transfusion to facilitate Hanjin vessels’ cargo unloading in the U.S. ports. Below are quick updates regarding upcoming schedules. Hanjin...
UPDATE 07-07-2017: The next compliance date is in March 2018. Importers should spend this time developing the programs as it takes time to work with Foreign Suppliers to build a robust FSVP program. FDA recently published a Federal Register notice announcing delays...
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