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Home » Store » Webinar Recordings » Choosing the Right Drug Approval Pathway - Webinar Recording/Transcript

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Audio Recording/Transcript - Feb. 21, 2018

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Choosing the Right Drug Approval Pathway - Webinar Recording/Transcript

$287.00
Webinar Recordings

Product Details

Choosing the Right Drug Approval Pathway: Speedier Approvals with Less Risk

The 21st Century Cures Act has ushered in a new era of business friendliness. Helped along by a pro-business White House and Congress, the FDA wants to help get your new drugs to market.

This is the moment to discover how, with guidance from a top Washington lawyer.

Julie Tibbets Esq., a partner in the FDA regulatory practice of Alston & Bird, will help you figure out your own fast-track strategies, with specifics including:

  • 21st Century Cures Act implementation update, including FDA guidance-development activities
  • The latest FDA maze jargon: Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review — and what they mean to you
  • Strategic planning: Aligning R&D with regulatory approval pathways
  • Case studies
  • And much more!

Golden opportunities don’t come along every day. For new-drug developers, this is such a moment. Gain the tools to fast-track your innovative therapies ... ahead of the competition.

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