Pat Soon-Shiong, Chairman of Chan Soon-Shiong Family Foundation, Executive Chairman at ImmunityBio, and Executive Chairman of the Los Angeles Times, shared a post on X:
“This is the most forward looking approach the FDA has taken with the expansion of scientific knowledge today. Well done Vinay Prasad, Dr. Marty Makary. I love these statements:
“An appropriately designed study with a small sample size can support licensure of a product for which pharmacologic effect is aligned with biologic plausibility and congruent with observed clinical outcomes. That philosophy, in essence, embodies the plausible mechanism pathway.”
“Meanwhile, for patients and families, there is no time to wait. Nearly 30 years after the sequencing of the human genome, bespoke therapies are close to reality. The FDA will work as a partner and guide in ushering these therapies to market, and our regulatory strategies will evolve to match the pace of scientific advances.”
Title: FDA’s New Plausible Mechanism Pathway
Authors: Vinay Prasad, and Martin A. Makary
Read The Full Article.
More from Pat Soon-Shiong on OncoDaily.
