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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-389-7344
info@itbholdingsllc.com

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FDA REGISTRATION SERVICES

Companies can export or import products to or from the United States as long as the facilities that produce, store, or otherwise handle them are registered with the U.S. Food and Drug Administration (U.S. FDA), and prior notice of incoming shipments is provided to the FDA.

ITB HOLDINGS LLC assists companies around the world, including manufacturers, exporters, importers, distributors, and warehouses.

▪ OUR SERVICES ARE OFFERED 24/7

For the following products requiring FDA Registration: Foods, Dietary Supplements, Alcoholic Beverages, Medical Devices, Medical Apps, Prescription Drugs, Over-the-Counter (OTC) Drugs, Active Pharmaceutical Ingredients (APIs), Cosmetics, Radiation-Emitting Products, Vaccines, Blood & Biologics, Animal & Veterinary Products.

Just in case you feel the need to switch U.S. Agent, we make the process easy. Get the better service your company deserves.

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FDA REGISTRATION

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FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP)

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    FDA NEWS

    All doses of Eli Lilly & Co’s blockbuster new drugs, Mounjaro and Zepbound, to treat diabetes and weight loss are available in the U.S. after more than a year and a half of shortages.

    FDA approved first cellular therapy, Amtagvi, to treat patients with unresectable or metastatic skin cancer melanoma.

    A portion of the patient’s tumor tissue is removed during a surgical procedure prior to treatment. The patients’ T cells are separated from the tumor tissue, further manufactured and then returned to the same patient as a single dose for infusion.

    Medical Tourism: Treatments, Markets and Health System Implications.

    A growing trade in healthcare has involved the movement of patients across borders in the pursuit of medical treatment and health, a phenomenon commonly termed “medical tourism”.

    A U.S. federal appeals court upheld the Food and Drug Administration (FDA)’s 23-year-old approval of the widely used abortion pill mifepristone, but said a series of actions the agency took in recent years to make it easier to obtain went too far.

    The U.S. Justice Department will be asking the U.S. Supreme Court to review the 5th Circuit’s ruling.

    U.S. Toll Free Number:

    If the label does not include the required domestic address or phone number through which the responsible person (manufacturer, packer, distributor, or retailer identified on the label) may receive a report of a serious adverse event associated with the use of the product, then it is misbranded.

    On March 18, 2023, U.S. Customs (CBP) deployed the Uyghur Forced Labor Prevention Act (UFLPA) Region Alert enhancement to the Automated Commercial Environment (ACE).

    This enhancement will provide an early notification to importers and their representative of goods that may have been produced in the Xinjiang Uyghur Autonomous Region (Xinjiang or XUAR) and may be excluded from importation into the United States.

    U.S. Food and Drug Administration to discuss whether a nasal spray version of the opioid overdose antidote Narcan should be made available over-the-counter.

    About 78 percent of active pharmaceutical ingredients manufacturers are located outside of the U.S.

    FDA products are manufactured or handled at nearly 275,000 registered facilities, more than half of which are overseas.

    There are over 20,000 prescription drug products approved for marketing.

    www.m.itbhdg.com

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    日本語 | Japanese

    東京、横浜、大阪、名古屋、札幌、福岡、神戸、または京都に所在する貴社は、今すぐ米国 FDA 登録を更新する必要があります。 米国のエージェントとしてお手伝いします。

    中文 | Chinese

    为您在上海、北京、天津、深圳、广州的公司注册美国FDA：节省时间和金钱。

    Don’t take a chance assuming that regulations in the United States, Canada, Mexico, Brazil, Australia, India, South Korea, China, Japan, Russia, European Union, are the same or similar.
    CURRENT FDA REGISTRATION TRENDS
    Food Facilities
    0%
    Medical Devices
    0%
    OTC Drugs
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    Depression affects nearly 21 million people in the United States.

    According to the American Psychiatric Association, more than 25 million people in the United States suffer from anxiety disorders involving persistent, excessive worry or fear of objects or situations, and recurrent panic attacks.

    A one-month supply of Ozempic, Novo Nordisk A/S’s diabetes drug that’s often used for weight loss, has a list price of $936 in the U.S., but just $169 in Japan. It’s about ten times more expensive in the U.S. than it is in Sweden.