FDA Regulatory Reform?

8 October 2018

An interview with Anthony Davies, Founder and CEO, Dark Horse Consulting.

The FDA recently issued a suite of six guidance documents, which will be the building blocks of an up to date and more comprehensive framework to ensure the advancement of the field of cell and gene therapy as well as ensuring that new products meet safety and efficacy standards.

Anthony Davies, Founder and CEO at Dark Horse Consulting gives his perspective on this newly proposed framework and some of the areas Dark Horse Consulting are providing feedback on. Here’s an overview of what is discussed in this video:

  1. A 60-second overview of the framework
  2. The greatest room for improvement
  3. How the proposed reforms better support early licensure
  4. The role that our industry must play in providing feedback and shaping these guidelines

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