Tag: FDA Agent registration
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FDA Drug U.S. Agent Requirement for Foreign Pharmaceutical Manufacturers
For foreign pharmaceutical companies planning to manufacture, export, or supply drugs to the United States, appointing an FDA Drug U.S. Agent is a mandatory regulatory obligation. The U.S. Agent serves as the official representative of the foreign drug establishment and acts as the primary communication channel with the United States Food and Drug Administration. Without…
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FDA U.S. Agent Registration
FDA U.S. Agent registration is a mandatory compliance requirement for foreign manufacturers and facility owners planning to register with the U.S. Food and Drug Administration. Without appointing an authorized U.S. Agent, a foreign establishment cannot successfully complete or maintain its US FDA establishment registration, regardless of product category. What Is FDA U.S. Agent Registration? An…