Simplifying Global Compliance
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.