FDA and regulatory guidelines allow for formal meetings between the FDA and sponsors or applicants to discuss the development and review of an investigational new drug (IND) application for drugs or biologic products. This meeting, known as a pre-IND meeting, is intended to address specific questions related to the initial US clinical study (also known as a first-in-human [FIH] study for new drugs and biologics) and other questions that could affect the IND application, including those related to the nonclinical program, manufacturing and product quality for the investigational product, and regulatory considerations. Once the meeting request has been submitted, it is up to the FDA to decide whether to grant or deny the request and to determine the appropriate format for an approved meeting. For pre-IND meeting requests (and requests for other “Type B” meetings), the FDA will typically respond within 21 days of receiving the request, and meetings are generally scheduled within 60 days of the request. Sponsors should therefore submit their request approximately two months before they would like to have the pre-IND meeting.Areas Covered Requesting a Pre-IND Meeting and TimelinesDifferent Types of Meetings Such as Type B and now Type DPrepare Meeting RequestPrepare Briefing PacketBest Tips and Best Practices for Successful Meetings Managing NegotiationsAssign roles and responsibilities for team members both during the preparatory stage and at the meetingOutline and rehearse contingency plansConsider the need for a formal presentationCritically evaluate preliminary feedback from the FDA and the implications for your programPrepare follow-up discussion points, questions, and “fallback positions” on key questions at the meetingTips and recommendations for all Sponsors/ApplicantsCourse Level - Basic/Intermediate/Advance (could be all categories)Who Should AttendChief Medical Officer, VP of Regulatory Affairs, Director of Regulatory Affairs, Manager of Regulatory Affairs, Regulatory Specialists, Consultants, R&D, CMC and even Biostatistics personnel will benefitWhy Should You Attend The information gained from the meeting can help ensure a complete IND application is submitted and potentially help avoid clinical holds.The meeting presents a formal opportunity to gather the FDA’s perspectives, recommendations, and preliminary agreement (or disagreement) on critical aspects of your development program.The meeting is an opportunity to build a constructive relationship with the FDA.Because the pre-IND (investigational new drugs) meeting represents a critical milestone in the regulatory process, it is important that sponsors maximize the value of the meeting. There is typically only one pre-IND meeting allotted per investigational product, so sponsors must prepare well for this meeting to ensure they get all the feedback they need to progress their development program.Phrasing and structure of questions is critical. So is adequate preparation and the key to a successful outcome at these meetings.Seize the opportunity to connect and establish rapport with the review division staff by using open and transparent communication.Learn the proven tips and best practices to address the Meeting Request, Briefing Packet to Post-Meeting Closure and your next steps with your submission and for a successful review and approval process.Dos and Don’ts: If you and your team decide to pursue a pre-IND meeting with the FDA, consider the hard-won advice to be provided. Your reputation with the agency is formed with this first impression. It’s critical to thoroughly prepare for any question the FDA might ask. Know your position and science clearly.