This webinar will cover a variety of FDA issues that are important to developers of new and generic drugs, biologics and biosimilars, devices and apps as well as regulated communications and how the FDA, under Dr. Gottlieb's leadership is becoming both more predictable in its actions via more directive guidances as well as more collaborative (acting as both regulator of and partner with regulated industries).
You will learn how the FDA's view of its mission is evolving and how it will impact policies for development, review, post-market surveillance and communications.
Dr. Gottlieb's intimate knowledge of the health industry psyche, viewed by some as his greatest flaw - is actually his most unique and important asset. He recognizes that predictability is power in pursuit of the public health and, in imagining an FDA that can (indeed must!) color outside the lines, pays heed to Bertrand Russell's maxim that, "Science may set limits to knowledge, but should not set limits to imagination."
Scott Gottlieb's tenure as Food and Drug Administration commissioner has, to date, been defined by two terms not generally associated with the agency that regulates more than a third of the U.S. economy - predictability and imagination.
"Imagination" and "Regulatory Policy" are not often used in the same sentence. But, the Gottlieb FDA is changing that. He recognizes that the agency must advance their relationships with the industries it regulates. That doesn't mean fewer in-depth reviews or strident actions. What it does mean is that the FDA is doing a better job being a first-among-equals intramural partner. From patient-focused drug development to biomarker vetting, responsible off-label communications, new approaches to pain management, and the regulatory science required for validating real-world evidence, Gottlieb is steadily moving the agency away from its traditional angst in "not invented here" regulatory conversations. He's not only imagining an FDA that is both regulator of and colleague with industry; he's working to make it a reality.
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