Tag: Can a drug be sold without FDA approval?
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FDA Drug U.S. Agent Services for Global Pharmaceutical Companies
For pharmaceutical manufacturers operating outside the United States, appointing an FDA Drug U.S. Agent is a compulsory step under US FDA regulations. Without a designated U.S. Agent, foreign drug establishments cannot complete US FDA Drug Establishment Registration or legally supply drug products to the U.S. market. The U.S. Agent acts as the official liaison between…
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US FDA Drug Registration: Complete Guide for Pharmaceutical Companies
US FDA drug registration is a critical regulatory requirement for organizations involved in the manufacturing, processing, packing, holding, or marketing of drug products regulated by the U.S. Food and Drug Administration. This process ensures that drugs entering regulated markets meet established standards of safety, quality, effectiveness, and labeling accuracy. XPRO America, a US FDA Consultancy,…