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What does the new FDA accelerated regulatory pathway mean for gene therapies?


U.S. Food and Drug Administration (FDA) commissioner Scott Gottlieb has announced that the drug agency is developing a system by which innovative gene therapies could be sped through the regulatory process. In a speech to board members of the Alliance for Regenerative Medicine, Dr. Gottlieb spoke about the challenges associated with reviewing cell and gene […]

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Webinar 2: U.S. lessons learnt from Kymriah & Luxturna

In the second of three webinars, P4A is focussing on the US environment for gene therapies. Single application cell and gene therapies in the US face health insurance challenges driven by a short-term focus, disconnection between price reporting and outcomes value, and complex distribution models…

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In our mission to understand and influence the debate on Orphan Drugs, P4A will be closely following industry and scientific conferences including attending some of them.

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