Top Ten Best Practices for Effective Communication with FDA on Product Development IssuesApril 30, 2009
One of the most important elements of a product development program is interaction with the FDA. Quality communication with the Agency can greatly improve the speed of the development process, from pre-IND/IDE submission through product approval and commercialization. While meetings with the FDA can be stressful, they are also essential to gain a clear understanding and direction from the Agency. The following are 10 recommendations for accomplishing a successful product development meeting with the FDA.
1. Prepare an accurate and crisp briefing package. At least 30 days before the meeting, the FDA will require a briefing package to be submitted. If the briefing package is not provided, the Agency can cancel the meeting. In this briefing document, a cross-functional project team can ask direct questions for FDA comments and recommendations. In order for the Agency to provide meaningful answers, the briefing document must contain accurate, complete, and detailed supporting information. This information will be the only data the FDA reviews when responding to the questions. However, because FDA reviewers are very busy, the document should be crisp and concise and not bog down the reviewers in unnecessary details.
2. Have specific requests and goals. Most FDA meetings last for only one hour. To make the best use of this time, the cross-functional project team should set out specific questions and goals to achieve in the meeting. The team's Regulatory Scientist should drive the meeting towards obtaining answers to the questions, so that goals can be met. This way, when the meeting is over, the next steps will be evident and the team will have a clear understanding of where to go.
3. Be prepared. To ensure a useful meeting, it is essential that the cross-functional project team anticipate questions that the FDA may pose, and prepare thoughtful, complete responses. The team should know their own information (which was provided to the FDA in the briefing package), and be prepared to answer questions based on notes provided by the Agency. One way to prepare is to create a list of potential questions, assign a team member to answer them, and then rehearse. This will give the team an opportunity to ensure that the answers are complete and accurate. Also, by rehearsing answers to potential questions, the team will learn how to direct the conversation in a helpful manner. Because answers could lead to follow-up questions, the team should be prepared to answer those as well.
4. Be a good listener. During the meeting, the sponsor should take into account what the team wants to communicate, but leave lots of time for the FDA reviewers to talk. Sometimes, a sponsor will assume that the meeting will be nothing more than a presentation. However, a sponsor can learn the most about the FDA reviewers and their concerns with the sponsor's product from the types of questions the reviewers ask and how they converse with the team. The reviewers' insights and comments will be invaluable to the team as its application and development programs are reviewed.
5. Be honest and transparent. In any project, unexpected situations may arise. The sponsor should be up-front and honest about unforeseen issues that have happened during the development program. Honesty not only allows the sponsor to maintain its professional integrity, but also helps to keep it out of legal trouble. Additionally, while communicating with the FDA, it is imperative that the sponsor be as transparent as possible. Transparency allows the sponsor to be proactive and explain confusing issues, instead of waiting for FDA questions. This fosters trust and professionalism between the FDA and the sponsor.
6. Be flexible. The FDA review teams are responsible for many projects that need to be reviewed concurrently. The sponsor should be flexible in regard to meeting with the Agency. This flexibility includes early/late meeting times, teleconferences instead of face-to-face meetings, and dates earlier or later than those mandated by law.
7. Ask direct questions. The FDA will not be a consultant on clinical projects. When preparing briefing documents, and in meetings, clear and direct questions are best. By asking direct questions, sponsors can gain insight into what is important to the reviewers and obtain a clearer vision of what the Agency is expecting. Often, sponsors would like the FDA to respond in a certain way to questions that are being asked. The way in which a sponsor phrases its questions is important, as the questions can help the sponsor explain the situation and advocate for a positive response. However, sponsors must also ensure the questions present the facts in a balanced and factual manner.
8. Ask for clarification if direction is unclear. Communication from the FDA reviewers can be confusing at times. If their response is unclear, or contradictory to earlier feedback, the sponsor should seek clarification. When asking for clarification, the sponsor should provide context for the confusion and include text from its earlier communications or from the FDA's communications. This way, the reviewers will be better able to understand what is causing the confusion and clarify responses for the sponsor.
9. Know the regulations. There are different types of meetings that the FDA can request. A "Type A" meeting is an urgent meeting with information that will affect the critical path of development. This kind of meeting is rarely needed if the sponsor is in communication with the FDA throughout the development program. "Type B" meetings include End of Phase 2 and Pre-NDA meetings, which are required by law. Pre-IND meetings are also Type B meetings, but are not required. These meetings should occur within 60 days of the sponsor's request. Understanding the type of meeting needed, and providing an appropriate briefing package, will enable the FDA and the sponsor to communicate effectively.
10. Take your own meeting minutes. The FDA will take the official minutes of the meeting. However, sometimes what is captured in the FDA minutes is not the same as the sponsor's understanding of what was discussed. When the FDA sends its meeting minutes, if there are discrepancies, the sponsor has the responsibility to notify the Agency in a timely manner and request that the official minutes be amended. When responding with changes, the sponsor should be able to reference its own notes with decisions, action items, deliverables, and timelines that were discussed in the meeting.