If your Canadian, French or Italian company's products are any of the following, then an OTC Drug Establishment Registration is required, and not MoCRA Registration: Antidandruff shampoo Toothpaste containing fluoride Deodorant that is also antiperspirant Moisturizer and makeup marketed with sun-protection claims Sunscreens. ITB HOLDINGS LLC 390 North Orange...
Unlike other companies offering FDA Registration and Compliance Services, ITB HOLDINGS LLC does not charge a separate fee for U.S. Agent. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.fda.itbhdg.com/product/fsvp/
Failure to update the FDA Registration of your Food Facility with an accurate DUNS number in accordance with 21 CFR 1.230(b) before September 15, 2023, will result in Cancellation of the Registration. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577 https://www.itbh...
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), domestic FDF facility ($213,134), foreign FDF facility ($228,134), domestic CMO facility ($51,152), foreign CMO facility ($66,152), large size operation generic drug applicant program ($1,620,556), medium size...
If a manufacturer's medical device falls into a generic category of exempted class I devices, a premarket notification application and FDA clearance are not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list their products. ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Or...
