The African Continental Free Trade Area (AfCFTA) began operating on January 1, 2021, and when fully implemented will be among the largest free trade a...
Premarket Notification 510(k) is not required before marketing Class I as well as some Class II dental medical devices in the United States. ITB HOLDI...
Which companies must renew their FDA Registration between October 1 and December 31, 2022? Food Facilities Food Canning Establishments (FCE) Drug Esta...
Holiday shopping is expected to increase to more than $1 trillion. In fact, inflation could even propel holiday sales. Cyber Monday online sales could...
Establishment Registration and Process Filing for Acidified and Low-Acid Canned Foods: all plant personnel involved in acidification, pH control, heat...
FDA Compliance: some of us have to work on Thanksgiving Day, BlackFriday and the rest of the week. Do you? ITB HOLDINGS LLC 390 North Orange Avenue, S...
Not all imported products sold as “supplements” are safe. Learn about some of the health fraud claims you should look out for! ITB HOLDINGS LLC 390 No...
For FY 2023, the FDA generic drug User Fee rates are: ANDA ($240,582), DMF ($78,293), domestic API facility ($37,544), foreign API facility ($52,544),...
FDA has completed its first pre-market consultation of a human food made from cultured animal cells. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2...
FDA Registration is required before shipping any regulated product to the United States, to avoid the detention of your shipment by the U.S. Food and ...