Tag: What is the difference between FDA and USFDA?
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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…
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FDA US Agent for Drugs and the Role of XPRO America
Foreign pharmaceutical manufacturers planning to sell drugs in the United States must comply with US FDA regulatory requirements. One of the most critical obligations is appointing an FDA US Agent for drugs. This requirement applies to all non US drug manufacturers, including API producers, finished dosage manufacturers, repackers, and relabelers. The US FDA mandates that…