Audio Transcript

You should submit a full information package, including clear, thoughtful questions to the designated Project Manager within 4 weeks of the pre-IND meeting. This will allow time for FDA to review your data and respond to your questions. The pre-IND meeting package should contain as much detailed information on the proposed drug development plan as possible. This package should also contain any background and/or preliminary information and data that can be provided, including:

• Product Name and application number (if applicable)
• Chemical name and structure
• Proposed Indication(s)
• Dosage form, route of administration, and dosing regimen
• A brief statement of the purpose of the meeting
• A list of specific objectives/outcomes expected from the meeting
• A proposed agenda
• A list of specific questions grouped by discipline
• Clinical data summary (this includes summary of literature articles if referenced and the NDA number of the reference listed drugs (if applicable)
• Preclinical data summary
• Chemistry, Manufacturing, and Controls (sufficient information to ensure identity, strength, quality, and purity of the product)

If you have proposed study protocols available, they should also be submitted. Your meeting package should contain detailed questions that you need the FDA to answer. The more detailed information you can provide us, the better we will be able to advise you.