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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.
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FOREIGN SUPPLIER VERIFICATION PROGRAM (FSVP)
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.
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。
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.
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.