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PIE is Good for You: Drive Patient Access by Embracing FDA's Final Guidance

Dean Hakanson, Jon Gonzales and Tara Alire


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In today’s age of value and affordability, life sciences companies struggle to establish evidence generation strategies that improve patient access to medications. They have also been slow to embrace the FDA’s recent final guidance on the pre-approval information exchange (PIE). R&D organizations can embrace the FDA’s final guidance by working hand in hand with payers earlier in the development process with the overarching goal of favorable coverage and reimbursement decisions.

In this new Pharmaceutical Executive article, ZS’s experts share three key steps to achieving this.