Tag: What is US FDA registration?
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FDA U.S. Agent ID: U.S. Representation Requirement for Foreign FDA Registrations
Foreign companies that manufacture or supply FDA-regulated products to the United States must appoint a U.S. Agent as part of their regulatory obligations with the U.S. Food and Drug Administration (FDA). This appointment creates an internal identification record commonly referred to as the FDA U.S. Agent ID, linking the foreign establishment to its authorized U.S.-based…
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US Drug Registration Guide: FDA Compliance for Drug Manufacturers
Any company planning to manufacture or supply drugs to the United States must comply with US Drug Registration requirements. These regulations are enforced by the U.S. Food and Drug Administration (FDA) and apply equally to US-based and foreign pharmaceutical companies. FDA drug registration is a legal prerequisite for market entry. Without it, drug products cannot…