This week's Fierce Biotech is brought to you by Egnyte.
In this webinar we’ll review the latest developments in the regulatory review process for gene and cell therapies, offering advice that companies can use to streamline their interactions with regulators, both in the U.S. and overseas.
- Understanding the FDA’s new guidance documents covering product development, accelerated approval pathways and other topics specific to gene and cell therapies.
- How to apply the lessons learned from Biomarin’s setback and other approval delays to improving development strategies for future gene and cell therapies.
- Comparing and contrasting the FDA’s policies for gene and cell therapies to those of regulatory bodies in other large global markets.
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