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. While the topics explored during pre-IND meetings may vary depending on the drug, development stage, and target indication, here are six issues rare disease sponsors should consider prior to engaging with the FDA:
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