You and your firm have spent thousands of hours and millions of dollars assuring your product is safe and effective. Now, you need to make sure it will receive Food and Drug Administration (FDA) approval. The key to achieving this is a perfectly executed Pre-NDA Meeting.
What is the Purpose of the Pre-NDA Meeting?
A Pre-NDA Meeting enables Sponsors and the FDA to ensure your New Drug Application (NDA) submission is well-organized and set up for success. This meeting should generally occur no less than 60 days before the submission date. Prior to the meeting, Sponsors should prepare for typical Pre-NDA Meeting questions over areas such as the formatting of the submission and inquiries regarding the evidence of effectiveness.
During the Pre-NDA Meeting with the FDA, the Sponsor will discuss the format and content of the anticipated NDA, with a specific focus on the presentation of the data that will be submitted.
When is a Pre-NDA Meeting needed?
Developing and submitting an NDA requires significant investments of both time and money. As such, when preparing to submit an NDA it is in your best interest to assure that your application does not land cold at FDA. At the same time, it is in the FDA’s best interest to be aware of upcoming work so it can be prepared with the required resources. The Pre-NDA Meeting allows each party to accomplish its objective.
Although a Pre-NDA Meeting is not a requirement, we would not recommend submitting an NDA without first meeting with the Agency. Drug development rarely goes exactly as planned, and keeping communication open with the Agency increases your chances of achieving success the first time around. A Pre-NDA Meeting also provides Sponsors with an opportunity to ask questions regarding any problems that are surfaced during the meeting or from prior interactions with the FDA, with plenty of time to address issues before the NDA submission. Accordingly, we advise anyone that is preparing to submit an NDA to schedule and attend a Pre-NDA Meeting with the FDA. Before this meeting, Sponsors will need to extensively prepare in order to make the most of this discussion.
Preparation for the Pre-NDA Meeting with the FDA
This meeting should generally occur no less than 60 days prior to the submission date. Prior to the meeting, Sponsors should prepare for typical Pre-NDA Meeting questions over areas such as the formatting of the submission and inquiries regarding the evidence of effectiveness. Sponsors should also review any advice that was given by the FDA for the NDA in prior meetings, and create detailed plans to address the remaining issues or subjects you need clarification on before the submission.
During the Pre-NDA Meeting, you must make the most of the opportunity to solicit comments and clarification from the FDA on the acceptability of:
- Pivotal clinical data, including late-breaking data that might become available for submission during the FDA’s review of the NDA
- Chemistry, manufacturing, and controls (CMC) information and, in particular, the extent of stability data
- Content of the Integrated Summary of Effectiveness (ISE) and Integrated Summary of Safety (ISS) sections
When you leave your Pre-NDA Meeting, you should have an understanding of the FDA’s expectation for content and formatting of the NDA submission and a firm estimation of your application’s readiness for filing and the likelihood of approval. For any unresolved issues that could affect the success of your NDA application, you should have a detailed understanding of the steps you’ll need to take to address these concerns.
Benefits of Having a Pre-NDA Meeting Consultant
Partnering with an FDA consulting firm when preparing for and conducting a Pre-NDA Meeting with the FDA offers several benefits. We have the necessary experience and knowledge to ensure that your Pre-NDA Meeting goes as smoothly as possible, leaving you in a position to succeed. By partnering with ProPharma Group for Pre-NDA Meeting guidance, some of the benefits you will receive include:
- We have been working with the FDA for more than 30 years and have prepared for and attended countless meetings with the FDA. As such, we know what is needed to achieve a successful interaction with the Agency and are uniquely qualified to help you achieve this
- Diversity of knowledge. ProPharma Group’s scientific and regulatory experts specialize in various disciplines and stay abreast of changing trends and current events. In short, we bring a unique and extensive range of knowledge and skills to the table, which is what you need to achieve a successful Pre-NDA Meeting with FDA
- The key to completing your Pre-NDA Meeting successfully is adequate preparation. However, this can be tricky if you are unsure of what is needed. That is why ProPharma Group is here to help. Due to the abundance of meetings that we have attended with the FDA, we know what is required and can help ensure that you are as prepared as possible for anything the Agency may throw your way
ProPharma Group: NDA Regulatory Experts
ProPharma Group will guide you through the Pre-NDA process by working with you to develop a clear, concise strategy, deliver complex information, and carefully execute all responses to the FDA. Our goal is to make your submission successful. We will also attend the Pre-NDA Meeting with you and hold a post-meeting debriefing session to discuss meeting takeaways, lessons learned, and next steps.