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Diane Publishing Books
New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts
Leslie G. Aronovitz (au)
Drug develop. requires testing of chemical compounds for their potential to treat disease. Before a new drug can be marketed in the U.S., a new drug application (NDA) must be approved by the FDA. Recent scientific advances have raised expectations that an increasing number of new & innovative drugs would soon be developed to prevent, treat, & cure serious illnesses. However, new drug develop., & in particular, develop. of new molecular entities has become stagnant. This report provides info: on: (1) trends in the pharmaceutical industry’s reported R&D exp. as well as trends in the number of NDAs submitted to, & approved by the FDA; & (2) experts’ views on factors accounting for these trends & their suggestions for expediting & enhancing drug develop. Ill.
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