Pre-submission regulatory meetings: Preparation

When developing a healthcare product, effective communication with your regulatory agency is critical. This holds especially true at key milestones, which may include (but are not limited to) pre-submission meetings for clinical trial and marketing applications* and end-of-phase 1 or end-of-phase 2 meetings. Pre-submission meetings provide both you and the agency a forum for sharing essential information about your healthcare product.¹

Regulatory agencies from different jurisdictions have specific procedures or requirements to successfully prepare for a pre-submission meeting, and applicants should adhere to these.

Product approval is ultimately determined by the scientific data that demonstrate a positive benefit-risk ratio related to product safety, efficacy and quality for use in a specific indication. Nevertheless, appropriately preparing for milestone meetings with your regulatory agency, particularly around issues that need resolution, can mean the difference between a timely product approval and costly delays with multiple review cycles or even a refusal of the application.²

Characteristics of a pre-submission meeting

Typically, a pre-submission meeting should have the following characteristics. It should:²

• Establish clear objectives and a specific agenda, and be scientifically-based and data-driven. Identify what you aim to accomplish and develop a meeting agenda to facilitate the agency’s answer or feedback to the questions that are critical to product development and submission approval.
• Focus on discussing the plans and status of product development, presenting scientific data and proposals, and facilitating reaching a consensus on key scientific and technical issues that have arisen during various stages of product development.The outcome of the meeting should be used to evaluate “go” or “no-go” decisions for the next phase of product development.
• Focus on scientific or medical issues that directly relate to the product under development or to regulatory requirements and guidance documents.

It is important to remember that a regulatory agency differs from a regulatory consultant. Keep questions focused and specific (for example, “Is it acceptable to take this approach due to rationale xyz?”) and not open-ended (for example, “How should I develop this product?”).

Various guidance documents are available that detail the meeting process as well as the format and content of different types of pre-submission meetings. Although factors such as jurisdiction, different review divisions (for example, drug vs. medical devices), and the type of meeting may affect certain procedures, the following general principles apply.

Requesting a pre-submission meeting

All meeting requests should be in writing. Ensure that you include adequate information for the agency to assess the potential utility of the meeting^2,3 and to identify staff necessary to discuss the proposed agenda items. Ensure also that you follow the specific regulatory guidance related to the type of meeting that you are requesting.

For instance, in the US, a formal request to meet with concerning a drugs or a biologic should include:

• The product name and application number (if applicable)
• Product information (such as chemical name and structure)
• The proposed indication
• The type of meeting requested (type A, B or C)
• A brief statement of the purpose and objective of meeting
• A proposed agenda, and the estimated time needed for each agenda item and designated speakers.
• A list of specific questions grouped by discipline (the agency may grant or decline the meeting primarily on the basis of the detailed nature and specificity of the questions)
• A list of preliminary proposed attendees representing your company
• A list of agency staff or representatives of a particular discipline that you would like to have attend (if applicable)
• Suggested dates and times for the meeting
• Suggested meeting format (for example, face-to-face, teleconference, videoconference)
• An approximation of what and when supporting documentation will be sent to the agency.

Once a meeting is scheduled (such as a formal meeting with the FDA, or a pre-CTA meeting with Health Canada for drug and biologics), adhere to the specified timelines, format and content when preparing and submitting the required meeting package. This package should provide information relevant to the discussion topics (for example, a summary of non-clinical, clinical, and chemistry and manufacturing data) and enable the agency to prepare adequately for the meeting.^3,4

Before the meeting

In advance of the meeting² , consider whether the following are applicable to your meeting and prepare accordingly:

• Appoint a team leader to coordinate the company’s responses during the meeting.
• Identify the role of each member who will attend.
• Conduct a “dry run” to practice who will say what.
• Identify potential questions that the agency may raise and discuss how these questions will be addressed.
• If the agency has provided a “preliminary” response to questions submitted, review your approach of remaining issues so as to keep the focus on key items (for example, where clarification is required or disagreement exists).
  

During the meeting

During the meeting, strive to:²

• Seek consensus and resolve all issues professionally and scientifically so that product development can proceed.
• Keep the meeting focused and run it according to the proposed agenda.
• At the end of meeting, ensure both parties have a clear understanding about any actions that need to be taken―and by whom.

 After the meeting

After the meeting, remember the following:

• It is a good practice to submit your meeting minutes (official or not) to the agency.
• If issues are identified which need to be addressed, follow up on these promptly.

*Types of clinical trial applications may include:

• IND = Investigational New Drug
• CTA = Clinical trial application
• IDE = Investigational Device Exemption

Types of marketing applications may include:

• NDS = New Drug Submission
• NDA = New Drug Application
• BLA = Biologics License Application
  • MAA =  Marketing Authorization Application
  • PMA = Premarket Approval

Disclaimer

The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012

References

1. U.S. Food and Drug Administration. (2005, April). Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA products. Retrieved June 6, 2012, from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079748.pdf.
2. Grignolo, A. (2008). Chapter 4. Meeting with the FDA. In Pisano, D.J. & Mantus, D.S. (Eds.), FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics (2nd ed., pp.109-23). New York: Informa Healthcare.
3. U.S. Food and Drug Administration. (2009, May). Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM153222.pdf.
4. Canada. Pre-Clinical Trial Application (CTA) Consultation Meeting. Retrieved September 26, 2012, from http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_pre_application-eng.php.