FDA Advisory Committee meetings provide independent experts' recommendations on safety and efficacy of new medications. While it is not mandatory for all drugs to go through this process, it is often required for drugs that exhibit complex scientific properties, have safety concerns, or are being developed for unapproved indications. Preparing for these meetings requires an understanding of the process and procedures and developing a clear and concise presentation of the clinical data.


As a drug developer looking to gain regulatory approval for a new medication, navigating an FDA Advisory Committee meeting may be a crucial step in the process. These independent expert panels, consisting of physicians, statisticians, and members of the public, play an important role in evaluating efficacy and safety data and providing recommendations to help inform the FDA’s final approval decision. Successfully interacting with an Advisory Committee requires thorough planning, a comprehensive understanding of meeting procedures, submission guidelines, and preparation due to the complexity of issues to be discussed at the meeting.

The FDA convenes expert Committees, to obtain guidance on specific submission review questions. Both the FDA and sponsor have the opportunity to present key clinical data for both existing and investigational products to the Advisory Committee.  The committee then provides their expert opinion and comment on the specific questions posed by the FDA. While committee comments and votes are non-binding, their discussion of evidence carries significant weight in subsequent FDA determinations.

Why is an Advisory Committee Meeting scheduled?

An Advisory Committee meeting can be required:

  1. When a new drug or biologic exhibits complex scientific properties that warrant additional expert evaluation,
  2. When safety or efficacy concerns are raised during development that could influence risk-benefit considerations, or
  3. When novel development approaches are taken for an unapproved indication, patient group, or combination that would benefit from committee guidance.

If an Advisory Committee meeting is required, the FDA notifies the applicant in advance of the scheduled meeting and sponsors continue/begin the preparation process, which includes development of the key deliverables:

The Briefing Document provided to the Advisory Committee is critically important as it gives the independent expert panel their first exposure to the applicant's clinical data detailing the product's safety and efficacy profile, before engaging in discussions at the public meeting.

The presentation from the applicant should aim to objectively yet concisely summarize only the key findings and results from pivotal clinical trials.

For the question and answer portion of the meeting, it is important to be thoroughly prepared, which involves anticipating and practicing responses to questions committee members may ask – for example - regarding trial protocols, statistical analyses, safety data, and technical queries. Supplemental slides and analyses should be arranged to thoughtfully address any panel concerns, with the goal of maximizing the potential for a favorable recommendation.

The Key Factors for Success

Advisory Committee Research Start by understanding the audience. What is the committee’s composition? What meetings have been held? How many were for an indication? Importantly, how were the questions to the committee structured by the FDA? What issues were raised in Q&A?

Issue Identification Align on the key issues. What key issues did FDA raise in your previous meetings and correspondence? What concerns might the committee have related to Benefit/Risk assessment?

Messaging Strategy Develop a clear, concise and compelling messaging strategy. What key messages will you need to communicate in your briefing materials, presentation and responses to questions in order to address the issues identified?

Speaker Strategy When it comes to Advisory Committees that are convened for rare diseases for example, everyone must become an ‘educator’. This includes the applicant, external experts and open public hearing participants. Who are the best people to communicate the key messages from your company and how can external experts help?

Preparation & Practice It is important to ‘never ad lib an ad com’. The stakes are too high. Thorough preparation and coaching is critical, including the use of mock panels that are representative of the likely Advisory Committee roster and expert leadership of the overall process.

Conclusion

FDA Advisory Committees play an important role in providing recommendations to aid approval decisions. Therefore, navigating the Advisory Committee process requires extensive preparation, including carefully planning to address uncertainties, anticipate questions, and practice presentations. With the right approach, sponsors can help shape committee views in a manner supportive of recommendation for approval.

Stay up to date

Contact us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World

  • This field is for validation purposes and should be left unchanged.