FACT SHEET

6 Issues to Consider for Rare Disease Pre-IND Meetings

 

Make the most of your pre-IND meeting

Whether you’re working in rare diseases or a more common indication, this Premier Perspectives fact sheet highlights what you should consider as a sponsor prior to engaging with the FDA.

Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. Pre-IND meetings with the FDA give sponsors the opportunity to discuss their unique development challenges and determine where regulatory flexibility can be justified.

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