Getting solutions to patients can be a long and complicated process and working with the FDA is a key part of the sequence. Preparing for and understanding the FDA’s needs is essential to facilitate the path and shorten your time to approval.
Johnson & Johnson Innovation, JLABS is bringing together experts from PAREXEL Consulting to discuss the ins and outs of FDA meetings, who will pull from their vast experience to help guide us through these vital interactions. Topics will include:
· Understanding the FDA’s position; not just what it wants but why
· What to agree on now and later; What does agreement mean?
· The key to proceed
· Understanding the dynamics within the FDA
· Flexibility and norms and what they mean
· Experts, patients and advocates at meetings
· Meeting minutes and follow up
Understanding the process will help you better prepare for your meetings and build confidence in and ability to adjust your plan. Come prepared with your questions!