Driving the Deal: FDA Considerations

Overview


The Food and Drug Administration (FDA) has recently publicly recognized that collaboration is a key priority as they work to safely bring cutting-edge devices and treatments to market. On this episode of the Collaborative Transformation podcast series, Life Sciences lawyers Vernessa Pollard, Veleka Peeples-Dyer and Khelin Aiken discuss trends and opportunities in the market as they relate to deals involving FDA-regulated products, including:

  • Leadership transitions at the FDA, the push toward modernization of products and product development, and what that means for the life sciences and digital health dealmaking environment.
  • Benefits of the FDA’s new approach to transparency and collaboration with the life sciences industry for both companies and investors.
  • Industry collaboration opportunities emerging from FDA’s rare disease product development priorities, product specific guidance and fast-tracked designations.
  • The increased involvement of contract manufacturing organizations and contract research organizations in life sciences and what that means for collaborations and dealmaking.
  • The role of FDA programs like the Digital Health Software Precertification Program and rules like the 21st Century Cures Act in driving innovation in life sciences.

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