The Pink Sheet
Nancy Myers, Catalyst President and former FDAer, penned an op-ed in The Pink Sheet on the gene therapy wave and how US regulators can address it. Scientific leaps forward have opened the floodgates of interest and investment in gene therapy. As the tidal wave of gene therapy innovations approaches, the time is right to take a look at how the changing science is causing FDA’s CBER to evolve.
In this guest column opinion piece, Nancy weighs in on what US regulators are doing to prepare for adequate review of these innovative applications, and other actions CBER could take to ensure that it’s able to facilitate the expected onslaught of breakthroughs in this field.