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NETS - NDA or BLA

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What is an NDA or BLA and why is it important in drug development?

An NDA, or "New Drug Application," is the formal method for a drug manufacturer to apply for FDA approval to begin sale and marketing of a new pharmaceutical in the US. An NDA contains every piece of information about a drug, from its chemical composition to its packaging to the results from its clinical trials. A BLA, or "Biological License Application," is very similar to an NDA, and is an application with information about the manufacturing processes, chemistry, pharmacology, clinical pharmacology and medical effects of a biologic product (a medical product isolated from a natural source such as a human, animal or microorganism). Manufacturers need approval of NDAs and BLAs before they are allowed to market their products.

Drugs must undergo a separate marketing approval process in other countries. In Europe, for example, the European Medicines Agency requires a Marketing Authorization Application (MAA). This serves a similar purpose to an NDA.

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