According to the US Food and Drug Administration (FDA) definition, a generic drug is a product that is comparable to a reference listed drug (RLD) in dosage form, strength, route of administration, quality, performance characteristics and intended use.

Vigorous rules and regulations pertaining to abbreviated new drug application (ANDA) submissions are complex and the generic drug industry strives to meet these in their efforts to obtain approval for a product.

Generics companies must be highly skilled and disciplined in product development and critically, establishing bioequivalence, to have a chance of being first to file.

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