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The Active Ingredient features expert insights and commentary from leaders of ZS Associates' global pharmaceuticals practice.

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What It’ll Take to Follow in Gottlieb’s Footsteps: Protect, Innovate and Scale

Posted by Pratap Khedkar on Thu, Mar 21, 2019

Matt Furlow co-wrote this blog post with Pratap Khedkar.

Scott Gottlieb’s nearly two-year stint as commissioner of the FDA is coming to an end, and with the ink on his resignation letter barely dry, Norman Sharpless was appointed acting head. Gottlieb is a tough act for the former director of the National Cancer Institute to follow, even temporarily. Gottlieb brought welcome change to the agency and excelled across three ideal FDA leader focus areas—to protect, innovate and scale up—when historically, the agency’s focus had been heavily skewed to protect, was slow to innovate and was cautious to scale up.

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Topics: generics, Pratap Khedkar, Biosimilars, pharma manufacturer, regulatory, Scott Gottlieb, FDA Commissioner, product approvals

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