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KMID : 1142220130080010079
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Regulatory Research on Food, Drug & Cosmetic
2013 Volume.8 No. 1 p.79 ~ p.88
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Research on Strategic Approaches To Receive a New Drug Approval from U.S. FDA
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Moon Seong-Eun
Lee Jang-Ik
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Abstract
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The scale of Korean pharmaceutical market exceeds 1.8% of the worldwide one with nearly 10% of annual growth rate. However, the amount of pharmaceutical products exported to the United States from Korea has been under-representative with only a few new drugs approved by the United States Food and Drug Administration (FDA). This article summarizes some regulatory processes for new drug development in the United States, reports studies on strategic approaches to receive new drug approval from the FDA, and suggests the types of new drugs that are substantially marketable in the United States. The authors suggest four areas of strategic approaches to receive NDA approval from the FDA for the profitable drug development in the United States pharmaceutical market. Those include the effective use of the formal meeting process with proactive communications with the FDA, the strategic selection of drug product category such as new biologics, the efficient drug approval pathway such as 505(b)(2) application, and the unique indication areas such as rare diseases.
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KEYWORD
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FDA-sponsor meeting, biologics, 505(b)(2) application, rare disease, orphan drug
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