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....
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...
Since FY 2015, Congress has continuously raised the issue of inadequate border screening of food. Particularly, Congress has been concerned with designing an import control strategy that incorporates a comprehensive system of safeguard reviews, rather than solely...
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...
If you manufacture wearable fitness trackers or electronic massagers, determining how your product will be regulated is an important exercise. An erroneous conclusion can have a substantial impact on your business. At the end of July 2016, FDA published a final...
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. Importers, get ready: in May 2017, FDA will start enforcing its final...
The Food and Drug Administration (FDA) issued the final rule for using symbols in labeling of medical devices and certain biological products.[1] The rule will be effective mid-September 2016. Specifically, the new regulations allow symbols to “stand alone”, i.e.,...
Recently, Congress made a new move to nullify the USDA rule published in December 2015 to establish a catfish inspection program under USDA's Food Safety and Inspection Service (FSIS). On May 25, 2016, the Senate passed a joint resolution to disapprove USDA’s...
UPDATE 6/5/2018: Editor’s Note: On May 4, 2018, FDA published a rule stating it will be extending the compliance dates for the Nutrition Facts panel and Serving Size Final Rules to January 1, 2020 for manufacturers with $10 million or more in annual food sales....
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