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- Information included in a NDA is predicated on laboratory and animal preclinical studies and testing in humans (Phase 1-four clinical trials).
- In truth, a number of generic companies are sometimes permitted to market a single product; this creates competitors in the marketplace, sometimes resulting in lower costs.
- A drug sponsor’s request to the Food and Drug Administration (FDA) for approval to sell and market a new drug within the United States.
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- Generic competitors is related to lower drug prices, with the entry of the second generic competitor being associated with the largest worth discount.
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