The pre-IND meeting can be helpful in developing a strategy for drug development by

• Identifying studies that will support the initiation of clinical trials
• Discussing available methods to enhance development (click on each to learn more)
• Orphan Drug Designation
• Fast Track Designation
• Accelerated Approval
• Animal Efficacy Rule
• Discussing the differences between applications (click on each to learn more)
• Submitting a 505(b)(1) Application
• Submitting a 505(b)(2) Application