by Sheri Farsakh on 4/22/15
Request a Type B meeting for pre-IND guidance and start building that good rapport with the FDA. Acquire maximum benefit for your strategic plan by engaging the FDA to help facilitate the development process. Although the meeting is not required by the FDA, it is highly recommended and has become more common of a researcher to take this proactive approach prior to undergoing the long and expensive pathway through to regulatory approval. In an effort to ease the drug approval process, the FDA must be delivered an accurate understanding of what the sponsor hopes to obtain from the meeting. Be honest and forthcoming with your concerns. Your proposed study may contain potential issues you are unaware of yet can be identified in a pre-IND meeting, which in turn can decrease your encounter of costly delays. Position yourself with the ability to gain such valuable feedback by forming a pre-planned agenda based on specific scientific or regulatory issues. Focused and specific questions are what the FDA expects. It is never too early to seek the help you need in order to plan your meeting accordingly, while building a strong relationship with the FDA for a successful drug program. Integrium recommends scheduling your pre-IND meeting 6-8 months prior to IND submission.