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Driving the Deal: FDA Considerations [PODCAST]

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. 

© 2019 McDermott Will & Emery

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About this Author

Vernessa Pollard Pharmaceutical Attorney McDermott
Partner

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on...

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