Choosing the Right Drug Approval Pathway - Webinar Recording/Transcript

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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.

This presentation is right for clinical-stage drug and biologics developers innovating new therapies, especially for unmet needs and rare diseases. Specific job responsibilities include but are not limited to:

  • Executive suite
  • Regulatory/compliance
  • Clinical operations
  • Planning and development
  • Marketing and sales
  • Public affairs
  • Investor relations
  • Legal counsel

Julie Tibbets Esq., a partner in the FDA regulatory practice of Alston & Bird, works closely with clinical-stage companies on product development and approval strategies, and communicating to investors regarding those pathways.