Tag: How do I check if a drug is FDA approved?
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US FDA ANDA Drug Registration: Regulatory Pathway for Generic Medicines
The Abbreviated New Drug Application (ANDA) is the approval route used for generic medicines in the United States. Companies that wish to market a generic drug must submit an ANDA to the U.S. Food and Drug Administration (FDA) demonstrating that their product is equivalent to a previously approved reference listed drug (RLD). US FDA ANDA…
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US FDA Drug Registration: Step-by-Step FDA Registration & Drug Listing Guide
Entering the United States pharmaceutical market requires strict regulatory compliance. US FDA Drug Registration is a mandatory process regulated by the U.S. Food and Drug Administration (FDA) for companies involved in manufacturing, processing, or distributing drug products in the US. Without proper FDA registration and drug listing, drug products may be denied entry into the…
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US FDA Drug Company Registration: Step-by-Step Overview for Global Manufacturers
FDA drug company registration is a legal requirement for pharmaceutical companies that manufacture, process, repack, relabel, or distribute drug products for the United States market. Any domestic or foreign facility involved in these activities must be registered with the U.S. Food and Drug Administration before commercial distribution begins. The purpose of FDA drug establishment registration…
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Understanding the US FDA Drug Registration and Listing Database for Market Access
For pharmaceutical companies planning to sell drugs in the United States, compliance with the US FDA Drug Registration and Listing Database is not optional—it is a legal requirement. This database serves as the official record of drug establishments and products that are manufactured, processed, packed, or distributed for the US market. Every domestic and foreign…