Tag: What is US FDA registration?
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FDA U.S. Agent ID: Why Foreign Companies Must Appoint a U.S. Agent
Foreign companies that manufacture or supply regulated products to the United States must appoint a U.S. Agent as part of their compliance obligations with the U.S. Food and Drug Administration (FDA). The appointment of this representative generates an internal record commonly referred to as the FDA U.S. Agent ID, which links the foreign establishment to…
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US Drug Registration Process: How to Register Drugs with the FDA
The United States pharmaceutical market is one of the most tightly regulated in the world. Any company planning to manufacture, export, or distribute drug products in the US must comply with US Drug Registration requirements enforced by the U.S. Food and Drug Administration (FDA). Without proper registration and listing, drugs cannot be legally sold or…