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Getting Approval for Abuse-Deterrent Opioids in the Era of an Opioid Epidemic

February 14, 2018


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The Debrief on Briefing Documents: How to Maximize Your Briefing Book for FDA Advisory Committee Meetings

December 7, 2017

At an FDA Advisory Committee (ADCOM) meeting – one of the most important days in a product’s development – Sponsors typically have no more than 75 minutes to credibly and persuasively explain their entire development program. The stakes are high because the committee plays a key role in influencing the…

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The New FDA Focus: “Business as Usual” Now Includes Paying Attention to the Cost of Drug Development

October 19, 2017

In the “old days” (aka, last year), the FDA rarely mentioned the “cost of drug development.”  The line between research and development (R&D) costs and regulatory was clear and not to be breached.  And when the term “price” entered the vernacular, FDA officials were consistent in their message that the…

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Contextual Intelligence in Value Communications: Managing Stakeholder Conflict & Building Consensus

October 2, 2017

In my last post, I discussed the role that contextual intelligence (CI) (understanding stakeholder emotions, behaviors, and beliefs) plays in the collaborative and transparent communication of a product’s value.

But how do pharmaceutical and device teams use CI to successfully communicate in an increasingly complex healthcare environment – one currently defined by a growing number of powerful, vocal, and sometimes competing stakeholders? In this post, I explore practical ways to leverage the information from CI to achieve consensus among conflicting stakeholder

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