You should leave an FDA meeting with answers to critical questions and an understanding of the FDA’s expectations. To the best extent possible, any meeting with the FDA should end in clarity and whoever is working on your project must ensure this happens.
To achieve your goals at a meeting with the FDA, the interaction must be carefully planned and executed flawlessly, leaving the FDA with a good impression of your product and company. This requires experts with prior regulatory experience who know the appropriate time to request a meeting, what is needed to prepare the necessary paperwork, what to expect when meeting with the FDA, and what steps should be taken post-meeting.
As frequent advocates for companies before the FDA, The Weinberg Group takes your product and combines our knowledge of science, medicine, ethics, and regulations to prepare for each meeting. We will guide you step-by-step through FDA meetings during each phase of the development process including:
You have been planning for this moment for so long and it is finally here. You’re ready to begin testing your drug in humans but are not sure that the design of your studies is valid, or maybe you’re looking for confirmation that your rationale is sound. You need to attend a Pre-IND Meeting with the FDA. The Pre-IND Meeting will allow you to communicate with the FDA early in the process, getting feedback on your drug development program before moving forward.
The Weinberg Group: Pre-IND Meeting Experts
The Weinberg Group will guide you through the entire Pre-IND process – from submitting the initial meeting request and supporting briefing document, through preparing for and executing the meeting. Our goal is to help you meet this critical milestone.
You have completed Phase 2 and are ready to move forward but need the Agency to review and agree upon your Phase 3 plan and protocol(s). You need to attend an End of Phase 2 Meeting. During this meeting you will present your Phase 3 and submission strategy; it is critical that this is done as effectively as possible to ensure that you are aligned with the FDA before you begin your Phase 3 pivotal program.
The Weinberg Group: Continuing to Phase 3
Experts from The Weinberg Group will work closely with you to ensure that your End of Phase 2 Meeting is as efficient and effective as possible, helping you obtain feedback from the Agency so that you can continue with your Phase 3 clinical trials.
You have spent endless amounts of time and money assuring that your product is safe and effective. You need to be sure it will receive FDA approval and are ready to obtain feedback from the Agency. The way to accomplish this? A perfectly executed Pre-NDA Meeting.
The Weinberg Group: NDA Regulatory Experts
We will work with you through the Pre-NDA process to develop a clear and concise strategy, communicate complex information, and strategically execute all responses to the FDA throughout the entire process. Our goal is to ensure that your meeting, submission, and product are as successful as possible.
You have overcome so many hurdles and navigated all of the obstacles that you encountered during the drug development process. The only thing standing between your product and NDA approval is an FDA Advisory Committee Meeting. The success of your product depends on the flawless execution of your meeting strategy.
Trust The Weinberg Group to help you navigate this final milestone. We will work with you to perfect your meeting strategy and assist with the preparation and execution of this critical meeting.