Trump to Pharma CEOs — 75-80% less FDA regulations…
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...
The Future of Medical Device Labeling is …. Electronic Submission
Last October, FDA published a proposed rule regarding the electronic submission of labels and package inserts for home-use medical devices, which are defined as devices labeled for use outside a professional healthcare facility and include diabetic test strips,...
Ben England to Moderate Panel Discussion at Seafood Expo North America
FDAImports Founder and CEO, Ben England, is moderating a panel discussion, “Why Pick on Me??? How FDA and the Partner Government Agencies Interact on Imports,” at the 2017 Seafood Expo in Boston. This session includes current and former officials from both Customs...
Customs Postpones Transitions of ACE for Certain Transactions
UPDATE 06/13/17: Customs has set an effective date for ACE- read here for more. Customs and Border Protection’s digital system – the “Automated Commercial Environment” (ACE) is only partially implemented. The U.S. trade community has long been aware of Customs and...
Food Facilities News Alert: FDA System Cancelling Registrations
Update: 2/27/2017 Based on our conversations with FDA, some facility registrations were cancelled because the US Agent failed to affirm the agency with FDA. However, we have had experiences where the US Agency was confirmed and the registration still cancelled....
Just Because You Can Make “Dietary Supplements” at Home Doesn’t Mean It’s Legal
Anyone manufacturing a product has a dream of building a brand. Like many other regulated industries, long-term success in the dietary supplement industry is dependent on regulatory compliance. A recent Consumer Reports article stated that anyone with a credit card...
Powdered Medical Gloves Bite the Dust
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....
Discussion Points: FDA’s New Deeming Regulations for Tobacco Products
On May 5, 2016, FDA finalized its tobacco deeming regulations, which will extend its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco products. These deeming regulations are intended to help implement the Family...
FDA Registration Renewal – Get Ahead of the Curve
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...
What to do when FDA Inspects your Device Facility
The FDA is coming! The FDA is coming! “This sums up my initial feelings in 2009, when I got the news that FDA was making a trip to our company,” recalls Schevon Salmon, an affiliated attorney. He was in charge of a medical device company’s compliance program during...