The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the...
If you did not obtain a DUNS Number, your U.S. FDA Registration may have been canceled. Your company risks cargo detentions, Import Alerts and Warning...
The Government of Indonesia recently announced it would import 2 million metric tons (MMT) of rice by December 2023 in order to fulfil its ongoing dis...
On March 24, 2023, FDA announced the rates for over-the-counter (OTC) monograph drug user fees (OMUFA) for fiscal year (FY) 2023. Facility fee rates i...
Temporary enforcement discretion for pending Unique Facility Identifiers (UFI) is no longer available. The option to select the “Pending UFI Option” f...
The Dietary Supplements Market size is projected to reach $220.8 billion by 2027, and more than one-third of Americans take dietary supplements in for...
When shipping your products to a U.S. Amazon warehouse, don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Au...
FDA REGISTRATION NUMBER Domestic and Foreign Companies. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855...
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),...
Indonesia’s ban on palm oil exports, make matters worse. Currently, Malaysia contributes over 50% of Certified Sustainable Palm Oil (CSPO) in the worl...
