Each month, a member of our Board of Editors leads the effort to develop in-depth, interesting feature articles for Regulatory Focus. With their years of experience and education, they get the opportunity to share their views on the month’s topic.
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This month’s theme is economics and regulatory strategy. Although it is still common for many regulatory professionals to be concerned only with the pure scientific/regulatory side of their work, as the profession has evolved over the years, the ambit of advice they provide has expanded—and with it, their need for knowledge of the entire product lifecycle, from the glimmer in an inventor’s eye, through research, trials, approval and even marketing. Many of these stages require an eye to the economics of product development, launch and even postmarket events.