FDA APPROVALS
controversial. The FDA will then incorporate this feedback into their decision regarding whether or not to approve a product. There are three key elements for a successful panel meeting: a collaborative relationship with the FDA; careful planning; and frequent, in-depth rehearsal. You can develop a collaborative relationship with the FDA by ensuring everything in your submission is based on sound science and in-depth knowledge of the regulations and guidelines relevant to your product. Be sure to foster a non-adversarial relationship from the start. It’s much easier than fixing a poor relationship later. When meeting with the FDA review team, listen carefully to determine any underlying concerns, not just the questions being asked. Work closely with and anticipate FDA concerns so that you can stay harmonised with the FDA on any arising issues. Collaborate with the FDA on the clinical data package to be used in the panel meeting. Consult with the designated federal official (DFO) for the panel meeting logistics, panel pack format and due dates, list of panel members, etc. Educate yourself and plan for everything
within your control. Learn from other panel meetings. They’re open to the public, so attend a few in person and/or watch live or recorded videos of prior meetings online. Ensure your team members view them to understand what procedures are followed during a panel meeting. It’s so much clearer when you see it in action after reading the FDA guidance documents. Realise that there could be other outside influences that could impact the outcome of your panel meeting. The open public hearing is typically one hour in length, and you should understand who might speak for or against your product. Patient advocacy groups and different physician specialties frequently choose to speak during panel meetings.
Research the panel members. What kinds of questions do each of the voting panel members ask, and what are their favourite hot topics? This is where viewing prior panel meetings will be helpful. You can also research each individual online to see what scientific publications they’ve authored. This will give you insights into their favourite topics. Understand the roles of the non-voting panel members, too. The industry representative is the only panel member you as
“There are three key elements for a successful panel meeting: a collaborative relationship with the FDA, careful planning, and frequent, in-depth rehearsal.”
the sponsor can work with. The industry rep represents the entire industry but can also be the sponsor’s ‘voice’ during panel meetings. This person can assist the panel with understanding the sponsor’s viewpoint or ask questions if misunderstandings exist. They can educate panel members about what is scientifically and technically feasible (from an industry and regulatory perspective). You can meet with the industry rep prior to the panel meeting to ensure knowledge of your data, potential issues that might arise, and potential questions that might be asked to bring clarity if it becomes clear that panel members are misunderstanding a key point. The patient representative provides the unique perspective of affected patients and family members. The consumer representative represents the consumer perspective and serves as a liaison between the committee and interested consumers, associations, coalitions, and consumer organisations.
The core presentation is the presentation your
speakers will provide on the morning of a panel meeting. You’ll include the key messages from your data and provide visual presentations of data (graphs, tables, etc). The data must always lead the way and provide context, whether that’s for the patient population (patient preference), disease state, etc. You’ll provide information regarding how your product fills an unmet clinical need. Best practice is to include only a single point per slide. You’ll want to prepare for any potential questions the panel might ask. This is your opportunity to clarify your key messages. What has the potential to be misunderstood or prompt a question? Organise your Q&A slides by topic and know what keywords you’re using to make searches easy and quick. Designate slides to be shown on screen versus those that contain talking points only. Clearly label slides to prevent accidentally showing a talking point slide. Practise with many different stakeholders to
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