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Achieve Success for Your US Product Application

Post thumbnail Achieve Success for Your US Product Application

The introduction of a new medicinal product to the US market follows a complex process that may extend many years from the initial discovery through to the US Food and Drug Administration (FDA) approval and market launch. There are many factors during the product development that impact the success of drug approval and launch, a thorough understanding of the regulations and requirements is often underrated. The drug development process is becoming increasingly specialized and the regulatory pathway that works for one program may not work or be applied to another program for the same indication.
In this webinar, we talk about:

What does it mean to “Begin with the End Goal in Mind?”
What information should an Investigational New Drug (IND) Application contain?
How to communicate with FDA as your partner
What are the FDA’s expedited programs?

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    Achieve Success for Your US Product Application

    Featured Speakers

    Mike Day
    Michael Day, PhD
    Senior Director a Regulatory Science
    As Senior Director Regulatory Science at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services…
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    Mark Gauthier
    Mark Gauthier
    Senior Director, Regulatory Science, Drugs & Biologics
    As Senior Director, Regulatory Science, Mark is responsible for assisting clients to define the regulatory strategies for the global development and…
    View profile