The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory...
The US drug approval process is long and costly, and pharmaceutical development companies pass the extensive costs of research, user fees, and monopoly rent on to American consumers. Essentially, U.S. patients have been...
We recently sat down with Customs and International Trade lawyers Jessica Rifkin and Roy León, to get their take on the current environment with respect to the White House, Customs, and inter-agency cooperation using the ACE system. Enforcement by Federal Agencies...
FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign...
Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and...
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...
Using the argument that the acceleration of scientific innovation and expansion of global markets require it, the Food and Drug Administration (FDA) is seeking new program models to meet the demands of a changing world. According to FDA, these needs led to the recent...
Healthy is a word that we use every day, but when we use it in terms of food labeling, the word takes on a more important and controversial meaning. In 2015, the FDA issued a warning letter to the KIND company stating that the use of the motto “healthy and tasty” on...
Editor’s Note: On September 29, 2017, FDA proposed to extend the compliance dates for the Nutrition Facts panel final rule to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food...
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for hundreds of facilities. Here are some things you need to know to ensure your renewal is completed...
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