Gene Therapy opinion piece – The Pink Sheet: Scientific Wave Pushes CBER Into Brighter Light

The Pink Sheet

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 in The Pink Sheet, former FDAer and Catalyst President Nancy Bradish Myers weighs in on what US regulators are doing to prepare for adequate review of these innovative applications, and what other actions CBER could take to ensure that it’s able to facilitate the expected onslaught of breakthroughs in this field.

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