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: