Over the past few years, a number of products that signal a new era of medical product development have entered the market or come on the horizon. Recently, the FDA approved four cancer drugs for use in patients whose tumors have specific genetic characteristics that are identified by a companion diagnostic test. This book describes the ways in which FDA has worked to respond to, anticipate and help drive scientific developments in personalized therapeutics and diagnostics. It provides a compendium of FDA’s many recent efforts to advance regulatory standards, methods and tools in support of personalized medicine and to further refine critical regulatory processes and policies in order to bring about personalized medical product development. This thoughtful book should serve as a useful resource for those looking toward a future where all stages of patient care-from prevention to diagnosis to treatment to follow-up-are truly personalized.
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