Communication with FDA when developing innovative pharmaceuticals and biologics is a key driver of success. Early and ongoing engagement with FDA can streamline development, reduce risks, and ensure that a company’s regulatory strategy aligns with FDA expectations. Various types of FDA meetings provide opportunities to receive feedback at different stages of product development. 

Why it’s Important to Understand the Different Types of FDA Meetings

For innovative products, it’s important to understand FDA’s perspective on product classification, development strategies, and potential regulatory pathways before investing heavily in research or manufacturing. By clarifying potential regulatory pathways and requirements early, sponsors minimize the risk of pursuing a development plan that FDA might later deem incomplete or problematic. 

Small pharmaceutical companies often have limited budgets. Getting concise FDA guidance early can save time and money, helping sponsors allocate resources more effectively and plan realistic timelines. Building a collaborative relationship with FDA from the start and clarifying the regulatory process can be achieved through setting initial meetings with the agency. 

Facet recommends meeting with FDA early and often to ensure streamlined and cost-effective product development.  This is especially true for small organizations that may not follow a traditional regulatory path, such as conducting early work outside the US or skipping phases in traditional product development.

Overview of Formal FDA Meetings

Formal FDA meetings are a cornerstone of the product development process, providing sponsors with the opportunity to engage directly with FDA and obtain critical guidance on their development programs. These meetings are structured interactions where sponsors can discuss their development plans, address regulatory issues, and receive valuable feedback from  FDA. The agency offers various types of formal meetings, each tailored to specific product types, purposes, and stages of development. The primary FDA meeting types for drugs and biologics include Type A, Type B, Type C, Type D, and INTERACT meetings. Each FDA meeting type serves a unique purpose. Understanding the nuances of these formal meetings can significantly enhance a sponsor’s ability to navigate the regulatory landscape effectively.

Early-Stage Development Meetings

These meetings help sponsors engage with FDA early in the product development process. They focus on foundational topics like study design, regulatory expectations, and potential risks to streamline development and avoid delays.

INTERACT / INTERACT LITE

For cutting-edge technologies like gene therapies and regenerative medicine products, FDA offers INTERACT (Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products) meetings which are newer meeting types created by the FDA to offer very early-stage, focused feedback on innovative product concepts. Traditionally, sponsors waited until a Pre-IND (Investigational New Drug) meeting to engage with FDA. However, for cutting-edge technologies (including but not limited to gene therapies and regenerative medicine products), waiting for a pre-IND meeting could result in significant time and resource investment without early regulatory insight. INTERACT meetings are intended to facilitate IND-enabling efforts where the sponsor is facing a novel, challenging issue that might otherwise delay progress of the product towards entry into the clinic in the absence of this early FDA input.

INTERACT LITE is a streamlined version of the INTERACT meeting. It’s designed for narrow or highly specific questions and operates under an even simpler request and response structure. This format allows sponsors to obtain targeted, high-level feedback quickly without the need for a full INTERACT meeting, which typically covers broader, more complex issues.

Milestone-Driven Meetings

Structured around key development milestones, these meetings ensure alignment between sponsors and FDA on critical data, study results, and regulatory pathways. 

Type B Meetings (Pre-IND, End-of-Phase 1, End-of-Phase 2)

Type B meetings occur at key points in development and are crucial for securing FDA guidance on study design, data adequacy, and regulatory expectations. These meetings have a 60 day lead time and can be requested as in-person, videoconference, teleconference, or written response only (WRO). Type B meetings include:

    • Pre-IND Meetings: Held before submitting an IND application, these discussions focus on preclinical data, manufacturing readiness, and clinical trial design.
    • End-of-Phase 1 (EOP1) Meetings: Conducted after Phase 1 trials, these meetings evaluate safety, tolerability, and preliminary pharmacokinetics to prepare for Phase 2.  Considerable discussion typically revolves around the design of a proposed Phase 2 study.
    • End-of-Phase 2 (EOP2) Meetings: A pivotal checkpoint before Phase 3 trials, these meetings ensure alignment on efficacy signals, patient population, and critical Phase 3 study requirements. Regulatory alignment at EOP2 is essential to designing a Phase 3 program that measures the most meaningful endpoints, maximizing the likelihood of a compelling and differentiated label at approval.
    • Type B (Pre-NDA/Pre-BLA):  Before submitting a New Drug Application (NDA) or Biologics License Application (BLA), sponsors can request a Type B meeting to discuss the content and format of their submission package. These discussions focus on clinical efficacy, safety data, labeling, and manufacturing quality to ensure the Sponsor provides all the necessary information for a smooth review.
    • Abbreviated New Drug Application (ANDA) Meetings:  For generic drug sponsors, ANDA Product Development and Pre-Submission Meetings help clarify FDA expectations regarding bioequivalence studies and submission requirements.

Flexible Scientific & Technical Discussions

Designed for ongoing engagement, these discussions allow sponsors to seek FDA input on evolving scientific and technical issues. They provide a forum for addressing questions related to development plans, nonclinical programs, individual study designs, manufacturing, or analytical methods. Often they are used when feedback from the Agency is desired between milestone meetings. 

Type C Meetings

Often referred to as “catch-all” discussions, Type C meetings address a variety of scientific and regulatory topics, including:

  • Development plans
  • Nonclinical studies and nonclinical data issues
  • Protocol amendments and study design changes
  • Possible indications
  • Manufacturing and quality control updates
  • Regulatory activities and assets (e.g., eligibility for breakthrough designation)

These meetings provide valuable insights at any stage of development and follow a 75-day scheduling timeline.

Critical Issue Resolution Meetings

Focused on resolving urgent or high-impact regulatory challenges, these meetings address significant scientific, safety, or clinical concerns that have stalled development. They aim to find solutions that keep development on track.

Type A Meetings

Type A meetings are reserved for urgent regulatory challenges, such as:

  • Resolving clinical holds
  • Addressing major disputes with the FDA
  • Restarting stalled development programs

These meetings occur within 30 days of a request and provide sponsors with actionable steps to move forward.

Type D Meetings

A newer category, Type D meetings offer rapid, focused feedback on narrow regulatory issues that do not require a full Type A or B meeting.  For example:

  • Follow up (non-clarifying) questions that arise about a new issue discussed after a Type A, B, or C meeting
  • General questions about innovative approaches to development that do not require detailed advice from the Agency
  • One or 2 focused topics on a highly complex single issue

Office of Orphan Products Development (OOPD) Meetings

For therapies targeting rare diseases, FDA’s OOPD meetings provide guidance on orphan drug designation, clinical development pathways, and potential incentives. Both formal and informal meetings can be held with OOPD.  

  • Formal meetings are designed to obtain clarification on orphan and rare disease designation submissions and discuss disagreements in recommendations or rulings

Informal FDA Interactions

Informal Meetings

Unstructured FDA interactions, such as phone calls or emails with FDA personnel, allow sponsors to address minor regulatory questions without a formal meeting request. These communications can be highly effective when sponsors have established strong relationships with FDA reviewers.

It is possible to have informal meetings with OOPD via teleconference.  The purposes of informal OOPD meetings include:

  • Questions about OOPD policies and procedures more generally
  • To obtain information about how to submit designation requests or grant applications
  • To receive feedback on formal definitions used by OOPD to make regulatory decisions
  • General advice on how to calculate incidence/prevalence estimates 

FDA Meeting Guidance from Facet Life Sciences

Engaging with the FDA early and often is essential for ensuring a smooth regulatory pathway. Each meeting type serves a specific purpose, from early-stage guidance to submission readiness and dispute resolution.

With so many meeting types, it is easy to see how it could be confusing for Sponsors to know which meeting is the right meeting!  At Facet, we help sponsors strategically plan FDA engagements to maximize efficiency, reduce costs, and accelerate product development. Our success is due to our rigorous preparation methods as well as our longstanding, exceptional reputation with FDA in providing the highest quality work. We help sponsors understand and leverage the right FDA meeting types, and properly prepare to navigate regulatory complexities with confidence.

Have questions about which meeting type is right for you? Let’s Talk!

The content above was based on the following guidances.  Link to them to see more detailed information!  If you are not sure how to interpret what you read in the guidance, consult with the experts at Facet!